Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496961
Other study ID # 81774443
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date December 1, 2021

Study information

Verified date March 2021
Source Shanghai University of Traditional Chinese Medicine
Contact Fei Yao, Doc
Phone 13585975106
Email doctoryaofei@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date December 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Yan Nian Jiu Zhuan Fa
Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education

Locations

Country Name City State
China Shanghai University of Traditional Chinese Medicine Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai University of Traditional Chinese Medicine Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Bakken IJ, Tveito K, Gunnes N, Ghaderi S, Stoltenberg C, Trogstad L, Håberg SE, Magnus P. Two age peaks in the incidence of chronic fatigue syndrome/myalgic encephalomyelitis: a population-based registry study from Norway 2008-2012. BMC Med. 2014 Oct 1;12 — View Citation

Capelli E, Lorusso L, Ghitti M, Venturini L, Cusa C, Ricevuti G. Chronic fatigue syndrome: Features of a population of patients from northern Italy. Int J Immunopathol Pharmacol. 2015 Mar;28(1):53-9. doi: 10.1177/0394632015572074. — View Citation

Exley C, Swarbrick L, Gherardi RK, Authier FJ. A role for the body burden of aluminium in vaccine-associated macrophagic myofasciitis and chronic fatigue syndrome. Med Hypotheses. 2009 Feb;72(2):135-9. doi: 10.1016/j.mehy.2008.09.040. Epub 2008 Nov 11. — View Citation

Lloyd S, Chalder T, Rimes KA. Family-focused cognitive behaviour therapy versus psycho-education for adolescents with chronic fatigue syndrome: long-term follow-up of an RCT. Behav Res Ther. 2012 Nov;50(11):719-25. doi: 10.1016/j.brat.2012.08.005. Epub 20 — View Citation

May M, Emond A, Crawley E. Phenotypes of chronic fatigue syndrome in children and young people. Arch Dis Child. 2010 Apr;95(4):245-9. doi: 10.1136/adc.2009.158162. Epub 2009 Oct 19. — View Citation

Pardini M, Guida S, Primavera A, Krueger F, Cocito L, Gialloreti LE. Amisulpride vs. fluoxetine treatment of chronic fatigue syndrome: a pilot study. Eur Neuropsychopharmacol. 2011 Mar;21(3):282-6. doi: 10.1016/j.euroneuro.2010.10.008. Epub 2010 Nov 26. — View Citation

Porter N, Lerch A, Jason LA, Sorenson M, Fletcher MA, Herrington J. A Comparison of Immune Functionality in Viral versus Non-Viral CFS Subtypes. J Behav Neurosci Res. 2010 Jun 1;8(2):1-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 6 months
Secondary 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. 6 months
Secondary 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. 6 months
Secondary 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.
6 months
Secondary 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. 6 months
Secondary 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. 6 months
Secondary 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. 6 months