Chronic Fatigue Syndrome
Conditions
Keywords
chronic fatigue syndrome, idiopathic chronic fatigue, red ginseng, cortisol, anti-oxidant
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.
Interventions
DIETARY_SUPPLEMENTred ginseng powder capsule
usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
DIETARY_SUPPLEMENTPlacebo
Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
Sponsors
Eun Jung Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. At least 19 years of age, but below 65 years of age 2. A subject who appear repetitive or continuous fatigue of unknown cause. 3. 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 4. A subject who voluntarily agrees to participate and signs after listening to explanation for purpose and characteristic about this clinical trial
Exclusion criteria
1. A subject who has history or PI for chronic fatigue 2. A subject who takes this drug in 2 weeks : antidepressant drug, anti-anxiety drug,sleeping pill, an antihistamine etc. 3. Pregnant, lactating women or a subject who has plan pregnancy. 4. A subject who receive medical treatment or takes dietary supplement(vit B,C etc) for chronic fatigue in 2 weeks. 5. A subject who has night duty, shift work or heavy work 6. A subject who is judged as being not fit by a specialist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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. |
| 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 |
| 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 |
| Thiobarbituric Reactive Acid Substances(TBARs) change | at 2(baseline) and 5(after 6 weeks of administration) visit | measure antioxidant levels in blood |
| 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 : 22:00-00:00 |
| 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 |
| 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 | — |
Countries
South Korea
Contacts
Primary ContactEun Jung Kim, Ph.D
Outcome results
None listed