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The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red ginseng powder capsule | Experimental | People in this group take a red ginseng powder capsule. |
|
| Placebo powder capsule | Placebo Comparator | People in this group take a placebo powder capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| red ginseng powder capsule | Dietary Supplement | usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Jung Kim, Ph.D | Contact | +82-31-710-3751 | hanijjung@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Eun Jung Kim, Ph.D | DongGuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk university Bundang Oriental Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13601 | South Korea |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| Placebo | Dietary Supplement | Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks |
|
| 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 |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |