Clinical trial NCT03496961: Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes
Official title: Shanghai University of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Fatigue Syndromes
Keywords: Yan Nian Jiu Zhuan Fa
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Yueyang Integrated Medicine Hospital
First posted: 2018-04-12
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinically evaluated, medically unexplained fatigue of at least 6 months duration:

Of new onset. Not a result of ongoing exertion. Not substantially alleviated rest and associated with a substantial reduction in previous levels of activity
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

The occurrence of four or more of the following symptoms:

* Subjective memory impairment
* Tender lymph nodes
* Muscle pain
* Joint pain
* Headache
* 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
* Dementia
* Anorexia or bulimia nervosa
* Alcohol or other substance misuse
* Severe obesity.

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 6 months
Secondary outcomes:
measure: Short Form 36-item Health Survey (SF-36)
timeFrame: 6 months
measure: Brain functional connectivity
timeFrame: 6 months
measure: Bristol Stool Scale
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
measure: Neuropeptide Y
timeFrame: 6 months
measure: Substance P
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine
Study officials:
References:
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