A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng

Study Overview
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Brief Summary
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The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.

Detailed Description
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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.

Official Title
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A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng

Conditions
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Chronic Fatigue Syndrome

Intervention / Treatment
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* Dietary Supplement: red ginseng powder capsule
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red ginseng powder capsule<br>People in this group take a red ginseng powder capsule. | Dietary Supplement: red ginseng powder capsule<br>* usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks<br>|
| Placebo Comparator: Placebo powder capsule<br>People in this group take a placebo powder capsule. | Dietary Supplement: Placebo<br>* Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100mm visual analogue scale(VAS) about fatigue change | 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' | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue severity scale change | The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items | 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 | The Chalder fatigue severity questionnaire is composed of 11 questions about fatigue. Grading of each item ranges from 0 to 9, where 0 indicate non-fatigue and 9 strong fatigue | 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 | 
| a short form of stress response inventory,SRI-short form change | SRI-short form is composed of 22 items about stress response. 22 items are classified into three categories(Somatization,anger and depression). | 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 | 
| beck depression inventory, BDI change | When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. | at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit | 
| insomnia severity index, ISI change | The ISI is composed of seven items assessing recent problems with sleep onset, sleep maintenance and early morning awakening, interference of sleep problems with daily functioning and perceived prominence of impairment attributed to the sleep problem, concern about sleep problems and satisfaction with sleep patterns. Perceived severity of each item is rated on a 0-4 scale and a total score, which ranges from 0 to 28 obtains from summing the items ratings | 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 | The EuroQOL - 5 Dimensions (EQ-5D) was employed for measuring health-related quality of life. It consisted of a weighted sum of five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression, which provided a simple descriptive profile and a single index value for health status . We used a recently developed version, the EQ-5D-5L, which includes five-level response options: no problems, slight problems, moderate problems, severe problems, and extreme problems | 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 | 
| derivatives of Reactive Oxygen Metabolites (d-ROMs) change | measure antioxidant levels in blood | at 2(baseline) and 5(after 6 weeks of administration) visit | 
| Biological Antioxidant Potential (BAP) change | measure antioxidant levels in blood | at 2(baseline) and 5(after 6 weeks of administration) visit | 
| Thiobarbituric Reactive Acid Substances(TBARs) change | measure antioxidant levels in blood | at 2(baseline) and 5(after 6 weeks of administration) visit | 
| Superoxide Dismutase(SOD) change | measure antioxidant levels in blood | at 2(baseline) and 5(after 6 weeks of administration) visit | 
| Stress hormone test | measure cortisol level in saliva First saliva sample : 07:00-09:00 (within 30 minutes after waking up) Second saliva sample : 11:00-13:00 Third saliva sample : 16:00-18:00 fourth saliva sample : 22:00-00:00 | at 2(baseline) and 5(after 6 weeks of administration) visit | 
| ginseng subjective symptoms questionnaire change | ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng | at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic fatigue syndrome, idiopathic chronic fatigue, red ginseng, cortisol, anti-oxidant