Shanghai University of Traditional Chinese Medicine
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Multidimensional Fatigue Inventory (MFI-20)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Yan Nian Jiu Zhuan Fa
The kneading process will be done under the therapist guidance for 30 minutes with an average pressure of 5 Newton each time for 3 times every day.
Intervention: Yan Nian Jiu Zhuan Fa (Behavioral)
cognitive psychology education
Psychological counseling and behavioral cognition education are conducted once a week and the rest 6 times online or by phone.
Intervention: Yan Nian Jiu Zhuan Fa (Behavioral)
blank control
this group will have no therapeutic exercises or cognitive education when other two groups receive therapy.
Outcomes
Primary Outcomes
Multidimensional Fatigue Inventory (MFI-20)
Time Frame: 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).
Secondary Outcomes
- 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)