CTRI/2025/02/080481尚未招募2 期
Efficacy of Jawarish Falafali in Chronic Fatigue Syndrome : A Randomized Double-blind Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in Chalder Fatigue Scale
研究概览
简要总结
Purpose: To Evaluate the Efficacy of Jawarish Falafali in Chronic Fatigue Syndrome
Design: A randomized double-blind placebo controlled clinical trial
Intervention: A test group will be given Jawarish Falafali 12gm in two divided doses, and a Placebo (Wheat flour) will be given in the same as of test group.
Main Outcome Measures:
Primary outcome: Improvement in Chalder Fatigue Syndrome
Secondary outcome: Improvement in FibroFatigue Scale, Improvement in SF-36 Quality of life Scale, Improvement in Subjective parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of CFS/ME according to the Fukuda criteria.
- •Age ranges from 18 to 60 years.
- •All genders.
- •Voluntary participation and signing the informed consent.
排除标准
- •known cases of anemia, thyroid disorder, vitamin B12, folate deficiency Newly diagnosed and known cases of diabetes mellitus systemic illness like rheumatoid arthritis, cardiovascular disease, respiratory illness, coeliac disease, IBD, epilepsy, carcinoma, etc known cases of severe depression or cases diagnosed with depression according to PHQ 9 questionnaire chronic alcoholism drug abuse subject with uncontrolled hypertension more than 140/90 mmhg in patient already on antihypertensive medication pregnant and lactating women.
结局指标
主要结局
Improvement in Chalder Fatigue Scale
时间窗: 0th 10th 20th and 30th days
次要结局
- Improvement in Fibro Fatigue Scale(Improvement in SF-36 Quality of life Scale)
研究者
Dr Ishrat Mohammed Israr
National Institute of Unani Medicine
研究点 (1)
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