Effects of Yiqi Fuyuan Paste Formula in Chronic Fatigue Syndrome: A Randomized Double-Blind Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- FAI (Fatigue Assessment Instrument)
研究概览
简要总结
The goal of this clinical trial is to learn if "Yiqi Fuyuan Paste Formula" (a traditional Chinese medicinal paste made from medicinal and edible Chinese medicines and health food like Ginseng Radix et Rhizoma, Astragali Radix et Rhizoma, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Poria Cocos, Coicis Semen, Dioscoreae Rhizoma, Nelumbinis Semen, Angelicae Sinensis Radix, Lycii Fructus, Citri Reticulatae Pericarpium, Juglandis Semen, Longan Arillus, Sesami Nigri Semen, Jujubae Fructus, Glycyrrhizae Radix et Rhizoma, and fine ingredients) works to ease Chronic Fatigue Syndrome (CFS) symptoms in adults. It will also learn about the safety of "Yiqi Fuyuan Paste Formula". The main questions it aims to answer are:
- Does "Yiqi Fuyuan Paste Formula" help reduce CFS-related fatigue (measured by the Fatigue Assessment Instrument, FAI)
- What underlying bodily changes (shown in blood tests) might explain its effects.
Researchers will compare "Yiqi Fuyuan Paste Formula" to a placebo (a look-alike substance that contains no drug) to see if "Yiqi Fuyuan Paste Formula" works to ease CFS symptoms.
Participants will:
- Take "Yiqi Fuyuan Paste Formula" or a placebo every day for 2 months
- Visit the clinic before and after the intervention for checkups and tests
- Keep a diary of their symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 - 65 years old, gender not restricted;
- •Patients meeting the diagnostic criteria for chronic fatigue syndrome;
- •Patients identified as having an "qi deficiency" or "balanced" constitution according to traditional Chinese medicine body type assessment; ④ Voluntary participants who have signed the informed consent form.
排除标准
- •Those who have any of the following conditions will not be included in this trial.
- •Those with severe depression or other mental disorders, as well as severe diseases of the heart, brain, liver, kidney and hematopoietic system; ② Those who are known to be allergic to the ingredients used in the ointment and have a severe allergic constitution;
- •Women who are currently breastfeeding, pregnant or have the intention to get pregnant during the trial period; ④ Those who are currently participating in other medical clinical trials.
结局指标
主要结局
FAI (Fatigue Assessment Instrument)
时间窗: week4
次要结局
- SF-36 (The MOS 36-Item Short-Form Health Survey)(week4)
- QDC（Qi deficiency constitution score）(week4)
研究者
Xiao tian zhang
Director of the Preventive Health Center
ShuGuang Hospital