A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Eun Jung Kim
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 100mm visual analogue scale(VAS) about fatigue change
Study Overview
Brief Summary
The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.
Detailed Description
Verify the efficacy and safety after taking red ginseng for chronic fatigue syndrome or idiopathic chronic fatigue patient. They were verified through not only survey like VAS change about fatigue, fatigue severity scale, Chalder fatigue severity questionnaire, SRI-short form , BDI , ISI EQ-5D-5L, ginseng subjective symptoms questionnaire but also an anti-oxidant test and a salivary cortisol test after 6 weeks after taking red ginseng or placebo drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 19 years of age, but below 65 years of age
- •A subject who appear repetitive or continuous fatigue of unknown cause.
- •A subject who has not abnormal findings of blood pressure, complete blood cell count(Hb, Hct, WBC, glucose), biochemical examination(AST, ALT, creatinine), thyroid gland function test(TSH, FT4), Urine test(Urine glucose, Urine protein), Chest X-ray, and ECG for causing fatigue
- •A subject who voluntarily agrees to participate and signs after listening to explanation for purpose and characteristic about this clinical trial
Exclusion Criteria
- •A subject who has history or PI for chronic fatigue
- •A subject who takes this drug in 2 weeks : antidepressant drug, anti-anxiety drug,sleeping pill, an antihistamine etc.
- •Pregnant, lactating women or a subject who has plan pregnancy.
- •A subject who receive medical treatment or takes dietary supplement(vit B,C etc) for chronic fatigue in 2 weeks.
- •A subject who has night duty, shift work or heavy work
- •A subject who is judged as being not fit by a specialist
Arms & Interventions
Red ginseng powder capsule
People in this group take a red ginseng powder capsule.
Intervention: red ginseng powder capsule (Dietary Supplement)
Placebo powder capsule
People in this group take a placebo powder capsule.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
100mm visual analogue scale(VAS) about fatigue change
Time Frame: at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
The patient is asked to indicate their perceived fatigue intensity along a 100 mm horizontal line, where '0' represents 'no fatigue' and '100', 'unbearable fatigue'
Secondary Outcomes
- a short form of stress response inventory,SRI-short form change(at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- insomnia severity index, ISI change(at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change(at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- ginseng subjective symptoms questionnaire change(at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) and 5(after 6 weeks of administration) visit)
- beck depression inventory, BDI change(at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- derivatives of Reactive Oxygen Metabolites (d-ROMs) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
- Biological Antioxidant Potential (BAP) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
- check abnormal responses(at 1(screening),2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- fatigue severity scale change(at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- Chalder fatigue severity questionnaire change(at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration), 5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit)
- Superoxide Dismutase(SOD) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
- Stress hormone test(at 2(baseline) and 5(after 6 weeks of administration) visit)
- Thiobarbituric Reactive Acid Substances(TBARs) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
Investigators
Eun Jung Kim
Assistant professor
DongGuk University