Trial Outcomes & Findings for American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial (NCT NCT01500096)

Last Updated: 2018-07-10

Results Overview

Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

From baseline to week 4 (28 days of study drugs)

Results posted on

2018-07-10

Participant Flow

Study participants were recruited from 2/13/13 through 10/19/15 from local HIV specialty clinics.

Participants who met study criteria returned for an enrollment visit for randomization. Study drugs (placebo or ginseng) were dispensed by the Investigational Pharmacy. Participants were instructed to take study drugs daily for 28 days. They returned 2 wks after finishing taking study drugs for a final visit. No wash out or run-in periods.

Participant milestones

Participant milestones
Measure	American Ginseng 1000 mg/Day 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Overall Study STARTED	32	17	31	16
Overall Study COMPLETED	31	17	31	14
Overall Study NOT COMPLETED	1	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	American Ginseng 1000 mg/Day 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Overall Study Lost to Follow-up	1	0	0	2

Baseline Characteristics

American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	American Ginseng 1000 mg/Day n=32 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=16 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	Total n=96 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 7.5 • n=5 Participants	52.1 years STANDARD_DEVIATION 9.5 • n=7 Participants	53.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	50.2 years STANDARD_DEVIATION 4.83 • n=4 Participants	52.2 years STANDARD_DEVIATION 7.3 • n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	9 Participants n=4 Participants	44 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants	7 Participants n=4 Participants	52 Participants n=21 Participants
Region of Enrollment United States	32 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants	16 Participants n=4 Participants	96 Participants n=21 Participants

PRIMARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Population: There was one missing scale from the ginseng 3000 arm

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=30 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in Fatigue Severity Score (FSS)	-24.7 units on a scale Standard Deviation 18.6	-16.3 units on a scale Standard Deviation 18.6	-16.9 units on a scale Standard Deviation 15	-21.6 units on a scale Standard Deviation 16.0

SECONDARY outcome

Timeframe: Change in BFI scores from baseline to week 4 (28 days of study drugs)

Population: There was on missing questionnaire from the ginseng 3000 arm

Questionnaire: Change in the Brief Fatigue Inventory (BFI) from baseline to week 4. We compared BFI scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. We used the BFI Question that assess "Worst Fatigue" score: 0 to 90 scale. Higher scores means more fatigue; negative values mean less fatigue.The BFI was used to supplement the data obtained from the FSS.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=30 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in the Brief Fatigue Inventory	-44.2 units on a scale Standard Deviation 34.3	-26.5 units on a scale Standard Deviation 28.5	-42.7 units on a scale Standard Deviation 32.4	-37.9 units on a scale Standard Deviation 35.1

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Population: There was one missing questionnaire from the ginseng 3000 arm

Questionnaire: Change in Epworth Sleepiness Scale (ESS) score from baseline to week 4. The ESS is scale ranges from 0 to 24; higher scores mean worse sleep disorder while a negative score indicates less sleep disorder. The ESS was used to supplement the data obtained from the FSS.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=30 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in Epworth Sleepiness Scale	-5.74 units on a scale Standard Error 7.15	-6.35 units on a scale Standard Error 4.43	-6.97 units on a scale Standard Error 5.23	-5.93 units on a scale Standard Error 3.17

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Population: There was one missed PHQ9 in the ginseng 3000 mg arm

Questionnaire: Change in Patient Health Questionnaire 9 (PHQ9) score from baseline to week 4. The scale for the PHQ9 score ranges from 0 to 27; higher scores mean worse depression; negative scores indicate less depression. We compared PHQ 9 scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. The PHQ9 was used to supplement the data obtained from the FSS.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=30 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in Patient Health Questionnaire 9	-5.52 units on a scale Standard Deviation 4.76	-5.59 units on a scale Standard Deviation 4.84	-2.87 units on a scale Standard Deviation 4.20	-3.86 units on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Population: There was one missing ISI in the ginseng 3000 mg arm

Questionnaire: Change in Insomnia Severity Index (ISI) score from baseline to week 4. The ISI scale ranges from 0 to 28; higher scores mean worse insomnia while negative scores indicate less insomnia. The ISI was used to supplement the data obtained from the FSS.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=30 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in Insomnia Severity Index	-6.9 units on a scale Standard Deviation 6.07	-5.47 units on a scale Standard Deviation 5.15	-3.43 units on a scale Standard Deviation 5.49	-3.57 units on a scale Standard Deviation 5.17

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Questionnaire: Change in Medical Outcomes Study (MOS) HIV Health Survey score from baseline to week 4. We evaluated the MOS Energy Fatigue scores; the MOS scale ranges from 0-100; higher scores mean more energy. The MOS was used to supplement the data obtained from the FSS.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in Medical Outcomes Study HIV Health Survey	22.4 units on a scale Standard Deviation 20.9	17.6 units on a scale Standard Deviation 19.5	24.0 units on a scale Standard Deviation 22.0	23.1 units on a scale Standard Deviation 21.3

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Questionnaire: Change in Clinical Global Impressions (CGI) scores from baseline to week 4. CGI is an instrument for making global assessments of worsening or improvement during interventional trials. The subject rates the change in the overall status since beginning the intervention (ranging from: very much improved, much improved, minimally improved, no change, and minimally worse). We assessed the number of participants who rated "very much improved".

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Changes in Clinical Global Impressions	3 Participants	3 Participants	7 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Laboratory - Inflammatory Markers (IMs): Change in Interleukin (IL) -6 and soluble receptors of tumor necrosis factor (TNF) α 1 and 2 (sTNFR1 and sTNFR2) from baseline to week 4. Negative values indicate less change in inflammatory markers.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Inflammatory Markers IL-6	0.22 pg/ml Standard Deviation 1.18	0.53 pg/ml Standard Deviation 1.99	0.079 pg/ml Standard Deviation 1.63	0.33 pg/ml Standard Deviation 1.33
Inflammatory Markers sTNFR1	19.5 pg/ml Standard Deviation 135.5	-15.5 pg/ml Standard Deviation 154.5	15.2 pg/ml Standard Deviation 170.5	-6.24 pg/ml Standard Deviation 142
Inflammatory Markers sTNFR2	183.5 pg/ml Standard Deviation 667.9	4.08 pg/ml Standard Deviation 580.5	-207.7 pg/ml Standard Deviation 1156.1	-201.7 pg/ml Standard Deviation 1156.1

SECONDARY outcome

Timeframe: From baseline to week 5 (28 days of study drugs)

Laboratory: Change in absolute cluster of differentiation 4 (CD4) cell count from baseline to week 5. Negative values mean decline in CD4 cell count.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in CD4 Cell Count	3.45 cells per cubic millimeter Standard Deviation 111.5	56.6 cells per cubic millimeter Standard Deviation 147.5	-23.1 cells per cubic millimeter Standard Deviation 148.4	34.4 cells per cubic millimeter Standard Deviation 99.8

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Laboratory: Change in plasma HIV RNA from baseline to week 4. A negative value means a drop in plasma HIV RNA.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in Plasma HIV RNA	1.94 copies/mL Standard Deviation 6.19	-0.06 copies/mL Standard Deviation 4.78	1.32 copies/mL Standard Deviation 7.02	0.0 copies/mL Standard Deviation 0.0

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs).

Population: There was one missed PROMIS fatigue questionnaire in the ginseng 3000 mg arm.

Questionnaire: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue score from baseline to week 4. Change in PROMIS fatigue score from baseline to Week 4. The change in fatigue as measured by the PROMIS fatigue (Week 4 minus Baseline) using the Wilcoxon test. The PROMIS fatigue is a scale with normalized mean of 50 and standard deviation (SD) of 10. Higher mean values mean more fatigue and negative values indicate less fatigue.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=31 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=30 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=14 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Change in PROMIS Fatigue	-12.5 units on a scale Standard Deviation 11.8	-11.1 units on a scale Standard Deviation 11.0	-11.4 units on a scale Standard Deviation 10.9	-9.49 units on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: From baseline to week 4 (28 days of study drugs)

Adverse events (AEs) were assessed from baseline to wk 4 using the NIH Division of AIDS (DAIDS) Grading Toxicity Table, a well known tool used by NIH networks for assessing the severity of AEs in participants enrolled in clinical trials. Reporting the number of participants in each arm who experienced adverse events.

Outcome measures

Outcome measures
Measure	American Ginseng 1000 mg/Day n=32 Participants 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 Participants 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 Participants 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=16 Participants 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Number of Participants With Adverse Events in the Ginseng and Placebo Arms	30 Participants	16 Participants	31 Participants	13 Participants

Adverse Events

American Ginseng 1000 mg/Day

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo for American Ginseng 1000 mg/Day

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

American Ginseng 3000 mg/Day

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo for American Ginseng 3000 mg/Day

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	American Ginseng 1000 mg/Day n=32 participants at risk 4-week of American ginseng 1000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 1000 mg/Day n=17 participants at risk 4-week of placebo for American ginseng 1000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day	American Ginseng 3000 mg/Day n=31 participants at risk 4-week of American ginseng 3000 mg/day every morning American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.	Placebo for American Ginseng 3000 mg/Day n=16 participants at risk 4-week of placebo for American ginseng 3000 mg/day every morning Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks. Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day
Immune system disorders Low ANC	3.1% 1/32 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	5.9% 1/17 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	6.2% 1/16 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Respiratory, thoracic and mediastinal disorders Bronchitis	3.1% 1/32 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/16 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Surgical and medical procedures Hip Replacement	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	3.2% 1/31 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/16 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Hepatobiliary disorders Increased AST	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	3.2% 1/31 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/16 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/16 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Infections and infestations Cellulitis	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	5.9% 1/17 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	3.2% 1/31 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/16 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
General disorders Pain Right Index Finger	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	3.2% 1/31 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/16 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Renal and urinary disorders Kidney Stone	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	6.2% 1/16 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
General disorders Abdominal Pain	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	6.2% 1/16 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
Renal and urinary disorders Ureterolithiasis	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	6.2% 1/16 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
General disorders Right Flank Pain	0.00% 0/32 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/17 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	0.00% 0/31 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.	6.2% 1/16 • Number of events 1 • 4 weeks The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.

Other adverse events

Additional Information

Adriana Andrade

Johns Hokpins University

Phone: 410-955-7287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place