Trial Outcomes & Findings for To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis (NCT NCT03210519)
NCT ID: NCT03210519
Last Updated: 2020-09-16
Results Overview
value at 3 months minus value at baseline reported
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
baseline and 3 months
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Eleutherococcus Senticosus
Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Acanthopanax senticosus-mono formula 30mg/vial and Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
|
Placebo
Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Eleutherococcus Senticosus
Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Acanthopanax senticosus-mono formula 30mg/vial and Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
|
Placebo
Participants first received screening tests for up to 30 days. Eligible subjects were then given the investigational products (Fructus Ziziphi Jujube concentrated juice15ml/vial) to be taken orally once/day for 90 days. Patients with hyperacidity and gastroesophageal reflux were recommended to take it after meals.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Eleutherococcus Senticosus
n=11 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 13.1 • n=11 Participants
|
55.8 years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
60.1 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
4 Participants
n=10 Participants
|
10 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Erythropoietin (EPO)
|
-6000.0 u/mth
Standard Deviation 5916.5
|
-1714.3 u/mth
Standard Deviation 6264.1
|
PRIMARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Hemoglobin (Hb)
|
1.0 gm/dl
Standard Deviation 1.1
|
-0.1 gm/dl
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Red Blood Cell (RBC)
|
25.1 10^4 cells/ul
Standard Deviation 35.6
|
-7.8 10^4 cells/ul
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Hematocrit (Hct)
|
2.5 vol% RBC in blood
Standard Deviation 3.2
|
-0.3 vol% RBC in blood
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Mean Corpuscular Hemoglobin Concentration (MCHC)
|
-0.5 g/dl
Standard Deviation 0.3
|
-0.3 g/dl
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Mean Corpuscular Volume (MCV)
|
1.3 fl
Standard Deviation 3.0
|
1.7 fl
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Mean Corpuscular Hemoglobin (MCH)
|
0.0 Pg
Standard Deviation 1.1
|
0.3 Pg
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Intact Parathyroid Hormone (iPTH)
|
28.6 pg/ml
Standard Deviation 240.5
|
-97.9 pg/ml
Standard Deviation 149.3
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (TNF-alpha)
|
-17.2 pg/ml
Standard Deviation 16.1
|
-14.9 pg/ml
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: baseline and 3 monthsvalue at 3 months minus value at baseline reported
Outcome measures
| Measure |
Eleutherococcus Senticosus
n=9 Participants
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 Participants
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Interleukin 6 (IL-6)
|
-20.3 pg/ml
Standard Deviation 28.7
|
-0.7 pg/ml
Standard Deviation 41.2
|
Adverse Events
Eleutherococcus Senticosus
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eleutherococcus Senticosus
n=11 participants at risk
Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial
|
Placebo
n=10 participants at risk
Fructus Ziziphi Jujube concentrated juice15ml/vial
|
|---|---|---|
|
Gastrointestinal disorders
Subjects complained uncomfortable
|
18.2%
2/11 • Number of events 2 • 1 and 3 months
Vital signs and patients' self-evaluation of their tolerance and physical improvement was assessed by a structured patient questionnaire administered at months 1 and 3
|
0.00%
0/10 • 1 and 3 months
Vital signs and patients' self-evaluation of their tolerance and physical improvement was assessed by a structured patient questionnaire administered at months 1 and 3
|
Additional Information
Dr. Nae-Cherng Yang
Department of Nutrition, Chung Shan Medical University
Phone: 886-0936810214
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place