Trial Outcomes & Findings for Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis (NCT NCT02331589)

Results Overview

aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

3 weeks of KRG

Results posted on

2015-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Korea Red Ginseng (KRG) KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)	Placebo (for KRG) placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Overall Study STARTED	39	36
Overall Study COMPLETED	34	31
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Korea Red Ginseng (KRG) n=34 Participants KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)	Placebo (for KRG) n=31 Participants placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	45.8 years STANDARD_DEVIATION 12.7 • n=5 Participants	50.0 years STANDARD_DEVIATION 12.8 • n=7 Participants	47.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Korea, Republic of	34 participants n=5 Participants	31 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks of KRG

aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase

Outcome measures

Outcome measures
Measure	Korea Red Ginseng (KRG) n=35 Participants KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)	Placebo (for KRG) n=31 Participants placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Liver Enzymes aspartate aminotransferase	52.1 U/L Standard Deviation 30.7	59.1 U/L Standard Deviation 37.2
Liver Enzymes alanine aminotransferase	81.0 U/L Standard Deviation 43.7	81.6 U/L Standard Deviation 32.2
Liver Enzymes gamma glutamyl transferase	106.9 U/L Standard Deviation 68.6	139.3 U/L Standard Deviation 198.2
Liver Enzymes lactate dehydrogenase	226.7 U/L Standard Deviation 99.0	218.6 U/L Standard Deviation 34.1

SECONDARY outcome

Timeframe: 3 weeks of KRG

KRUPP's fatigue severity scale. The survey has nine questions as following: 1. my motivation is lower, when I am fatigued 2. exercise brings on my fatigue 3. I am easily fatigued 4. fatigue interferes with my physical functioning 5. fatigue causes frequent problems for me 6. my fatigue prevents sustained physical functioning 7. fatigue interferes with carrying out certain duties and responsibilities 8. fatigue is among my 3 most disabling symptoms 9. fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). Scores range from 9 to 63, with higher scores indicating higher fatigue

Outcome measures

Outcome measures
Measure	Korea Red Ginseng (KRG) n=35 Participants KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)	Placebo (for KRG) n=31 Participants placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Fatigue as Measured by KRUPP's Fatigue Severity Scale	33.0 scores on a scale Standard Deviation 11.6	29.8 scores on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: 3 weeks of KRG

tumor necrosis factor-alpha, interleukin-6

Outcome measures

Outcome measures
Measure	Korea Red Ginseng (KRG) n=35 Participants KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)	Placebo (for KRG) n=31 Participants placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Pro-inflammatory Cytokine tumor necrosis factor-alpha	108.0 pg/mL Standard Deviation 54.8	123.1 pg/mL Standard Deviation 42.1
Pro-inflammatory Cytokine interleukin-6	2.3 pg/mL Standard Deviation 1.9	1.5 pg/mL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 3 weeks of KRG

enzyme-linked immunosorbent assay

Outcome measures

Outcome measures
Measure	Korea Red Ginseng (KRG) n=35 Participants KRG capsule (3,000 mg/day) for 3 weeks KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)	Placebo (for KRG) n=31 Participants placebo (for KRG) for 3 weeks Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Adiponectin	7751.2 pg/mL Standard Deviation 3108.1	7711.6 pg/mL Standard Deviation 3041.3

Adverse Events

Korea Red Ginseng (KRG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (for KRG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ki Tae Suk

Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea

Phone: +82-33-240-5826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER