NCT02847845Unknown不适用
A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Eun Jung Kim
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 100mm visual analogue scale(VAS) about fatigue change
研究概览
简要总结
The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
100mm visual analogue scale(VAS) about fatigue change
时间窗: 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'
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- derivatives of Reactive Oxygen Metabolites (d-ROMs) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
- Biological Antioxidant Potential (BAP) change(at 2(baseline) 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)
- 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)
- 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)
- Superoxide Dismutase(SOD) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
- Stress hormone test(at 2(baseline) and 5(after 6 weeks of administration) visit)
- Thiobarbituric Reactive Acid Substances(TBARs) change(at 2(baseline) and 5(after 6 weeks of administration) visit)
研究者
Eun Jung Kim
Assistant professor
DongGuk University
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Ginseng in Treatment of Fatigue in Multiple SclerosisFatigueNCT01712373Isfahan University of Medical Sciences60
Unknown
不适用
Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic DiseaseSjögren's SyndromeRheumatic DiseasesKorean Red GinsengNCT03983408Hanyang University120
已完成
不适用
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal CancerColorectal CancerNCT02039635Korea Ginseng Corporation438
进行中（未招募）
1 期
The Effects of Ginseng on Cancer-Related FatigueAdvanced CancersSolid TumorsNCT01375114M.D. Anderson Cancer Center165
Unknown
早期 1 期
Treatment of CFS and Fibromyalgia With HRG 80 Red GinsengFibromyalgiaCFSNCT04599348Practitioners Alliance Network70