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Trial record 42 of 112 for:    Chronic Fatigue Syndrome

Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes (YNJZFCFS)

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ClinicalTrials.gov Identifier: NCT03496961
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Shanghai Yueyang Integrated Medicine Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndromes Behavioral: Yan Nian Jiu Zhuan Fa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

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.
Primary Purpose: Treatment
Official Title: Shanghai University of Traditional Chinese Medicine
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Yan Nian Jiu Zhuan Fa
Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education
Other Name: cognitive behavior education

Placebo Comparator: cognitive psychology education
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
Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education
Other Name: cognitive behavior education

No Intervention: blank control
this group will have no therapeutic exercises or cognitive education when other two groups receive therapy.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Short Form 36-item Health Survey (SF-36) [ Time Frame: 6 months ]
    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.

  2. Brain functional connectivity [ Time Frame: 6 months ]
    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.

  3. Bristol Stool Scale [ Time Frame: 6 months ]

    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.


  4. Pittsburgh Sleep Quality Index [ Time Frame: 6 months ]
    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.

  5. Neuropeptide Y [ Time Frame: 6 months ]
    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.

  6. Substance P [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496961


Locations
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China, Shanghai
Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 201203
Contact: Fangfang Xie, postgraduate    18616122048    1780402990@qq.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai Yueyang Integrated Medicine Hospital

Publications of Results:

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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03496961     History of Changes
Other Study ID Numbers: 81774443
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Yan Nian Jiu Zhuan Fa
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases