A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
- Conditions
- Chronic Fatigue Syndrome
- Interventions
- Dietary Supplement: red ginseng powder capsuleDietary Supplement: Placebo
- Registration Number
- NCT02847845
- Lead Sponsor
- Eun Jung Kim
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Red ginseng powder capsule red ginseng powder capsule People in this group take a red ginseng powder capsule. Placebo powder capsule Placebo People in this group take a placebo powder capsule.
- Primary Outcome Measures
Name Time Method 100mm visual analogue scale(VAS) about fatigue change 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 Outcome Measures
Name Time Method 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 SRI-short form is composed of 22 items about stress response. 22 items are classified into three categories(Somatization,anger and depression).
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 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
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 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
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 ginseng subjective symptoms questionnaire is composed of 13 items about subjective symptoms after taking red ginseng
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 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.
derivatives of Reactive Oxygen Metabolites (d-ROMs) change at 2(baseline) and 5(after 6 weeks of administration) visit measure antioxidant levels in blood
Biological Antioxidant Potential (BAP) change at 2(baseline) and 5(after 6 weeks of administration) visit measure antioxidant levels in blood
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 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
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 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
Superoxide Dismutase(SOD) change at 2(baseline) and 5(after 6 weeks of administration) visit measure antioxidant levels in blood
Stress hormone test at 2(baseline) and 5(after 6 weeks of administration) visit 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 : 22:00-00:00Thiobarbituric Reactive Acid Substances(TBARs) change at 2(baseline) and 5(after 6 weeks of administration) visit measure antioxidant levels in blood
Trial Locations
- Locations (1)
Dongguk university Bundang Oriental Hospital
🇰🇷Seongnam-si, Gyeonggi-do,, Korea, Republic of