Shanghai University of Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Multidimensional Fatigue Inventory (MFI-20)
研究概览
简要总结
This study is to disclose the mechanism of characteristic Tao yin exercises regulate Chronic Fatigue Syndromes based on Brain-Gut Axis.Explore the clinical manifestation of Chronic Fatigue Syndromes, changes of neurotransmitter and central brain function. Then provide some new methods of treating Chronic Fatigue Syndromes.
详细描述
This research will be conducted in Shanghai University of Traditional Chinese Medicine.Then the clinical efficacy of Yan Nian Jiu Zhuan Fa on Chronic Fatigue Syndrome will be observed by examining gastrointestinal function, affecting the content of substances in plasma and analysing the central nerve response mechanism.
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, Outcomes Assessor)
盲法说明
This will use simple randomization ways. Sofware20.0 will used to generate a random unique number for each integral number from 1 to 90 and divide the 90 numbers (1 to 90) into three groups with a ratio of 1:1:1 based on the random numbers group. The number grouping is unknown. This will be a double blind trial.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The occurrence of four or more of the following symptoms:
- •Subjective memory impairment
- •Tender lymph nodes
- •Muscle pain
- •Joint pain
- •Unrefreshing sleep
- •Post-exertion malaise lasting for more than 24 hours
排除标准
- •Active, unresolved, or suspected medical disease
- •Psychotic, melancholic or bipolar depression (but not uncomplicated major depression)
- •Psychotic disorders
- •Anorexia or bulimia nervosa
- •Alcohol or other substance misuse
- •Severe obesity.
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI-20)
时间窗: 6 months
A self-report instrument consisting of 20-item devised to measure fatigue, covering the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This instrument takes about 5 to 10 minutes to complete. The instrument's psychometric properties were tested and determined to have good internal consistency and construct validity in samples with Chronic Fatigue Syndrome (CFS).
次要结局
- Brain functional connectivity(6 months)
- Bristol Stool Scale(6 months)
- Neuropeptide Y(6 months)
- Pittsburgh Sleep Quality Index(6 months)
- Short Form 36-item Health Survey (SF-36)(6 months)
- Substance P(6 months)