An interventional study of Yan Nian Jiu Zhuan Fa in Chronic Fatigue Syndromes, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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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.
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.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
This study's planned enrollment of 135 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The occurrence of four or more of the following symptoms:
Exclusion criteria:
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.
Behavioral: Yan Nian Jiu Zhuan Fa
Psychological counseling and behavioral cognition education are conducted once a week and the rest 6 times online or by phone.
Behavioral: Yan Nian Jiu Zhuan Fa
this group will have no therapeutic exercises or cognitive education when other two groups receive therapy.
Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education
Also known as: cognitive behavior education
Multidimensional Fatigue Inventory (MFI-20)
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).
Time frame: 6 months
Short Form 36-item Health Survey (SF-36)
The SF-36 is an internationally well-validated measure of Health-related quality of life that has a broad scope of questions validated across different chronic diseases and comorbidities.
Time frame: 6 months
Brain functional connectivity
Functional connectivity density (FCD) is a newly developed data-driven method to measure the number of functional connections of each voxel, possibly providing new insight into the neural correlates of fluid reasoning.Functional magnetic resonance imaging (fMRI) is a novel method for studying the changes of brain functional connectivity.
Time frame: 6 months
Bristol Stool Scale
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. It is used in both clinical and experimental fields. The seven types of stool are: Scale 1: Separate hard lumps, like nuts (hard to pass), also known as goat feces or sausage-shaped, but lumpy. Scale 2: Like a sausage but with cracks on its surface or like a sausage or snake, smooth and soft. Scale 3: Soft blobs with clear cut edges (passed easily). Scale 4: Fluffy pieces with ragged edges, a mushy stool even watery, no solid pieces, entirely liquid. Scale 1 indicate constipation, Scale 2 being the ideal stools as they are easy to defecate while not containing excess liquid, Scale 3 tending towards diarrhea, and Scale 4 indicate diarrhea.
Time frame: 6 months
Pittsburgh Sleep Quality Index
A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
Time frame: 6 months
Neuropeptide Y
Neuropeptide Y (NPY) is a 36 amino-acid neuropeptide that is involved in various physiological and homeostatic processes in both the central and peripheral nervous systems. NPY has been identified as the most abundant peptide present in the mammalian central nervous system, which consists of the brain and spinal cord. It is secreted alongside other neurotransmitters such as glutamate.
Time frame: 6 months
Substance P
Substance P is a bioactive 11-amino acid peptide (Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-amide) first isolated in 1931 from brain and intestine. The peptide is involved in many physiological processes including pain modulation, smooth muscle contraction, blood pressure control, kidney function and water homeostasis.Substance P is widely distributed in numerous tissues and body fluids including the central and peripheral nervous system, gastrointestinal tract, respiratory tract, visual system and circulatory system.
Time frame: 6 months
Started Dec 2018 (actual). Primary completion is estimated for Jun 2021, 30 months after the start.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 30 months is above that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine →