Clinical trial NCT02847845: A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
Official title: A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: chronic fatigue syndrome
idiopathic chronic fatigue
red ginseng
cortisol
anti-oxidant
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 100mm visual analogue scale(VAS) about fatigue change
timeFrame: 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 outcomes:
measure: fatigue severity scale change
timeFrame: 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
measure: Chalder fatigue severity questionnaire change
timeFrame: 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
measure: a short form of stress response inventory,SRI-short form change
timeFrame: 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
measure: beck depression inventory, BDI change
timeFrame: at 2(baseline),5(after 6 weeks of administration) and 6(follow up evaluation after 10 weeks of administration) visit
measure: insomnia severity index, ISI change
timeFrame: 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
measure: EuroQol - 5 Dimensions - 5 Levels, EQ-5D-5L change
timeFrame: 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
measure: derivatives of Reactive Oxygen Metabolites (d-ROMs) change
timeFrame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure: Biological Antioxidant Potential (BAP) change
timeFrame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure: Thiobarbituric Reactive Acid Substances(TBARs) change
timeFrame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure: Superoxide Dismutase(SOD) change
timeFrame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure: Stress hormone test
timeFrame: at 2(baseline) and 5(after 6 weeks of administration) visit
measure: ginseng subjective symptoms questionnaire change
timeFrame: at 2(baseline),3(after 2 weeks of administration), 4(after 4 weeks of administration) and 5(after 6 weeks of administration) visit
measure: check abnormal responses
timeFrame: 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
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Dongguk university Bundang Oriental Hospital
state: Gyeonggi-do,
Study officials:
affiliation: DongGuk University
name: Eun Jung Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: