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Chronic Fatigue SyndromesYNJZFCFSNCT03496961

Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes

A study testing Yan Nian Jiu Zhuan Fa in people with Chronic Fatigue Syndromes, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Chronic Fatigue Syndromes
What is being tested?
Yan Nian Jiu Zhuan Fa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
1 siteChina
Study dates
1 Dec 2018to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Fei Yao, Doc contact

13585975106

doctoryaofei@126.com

China1 site, 1 recruiting

  • Shanghai University of Traditional Chinese Medicine

    Shanghai, 201203

    Fangfang Xie, postgraduate, 18816515192, 1780402990@qq.com

    Recruiting

Other trials in China

About this study

Official title: Shanghai University of Traditional Chinese Medicine

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.

Read the 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.

Being tested
Yan Nian Jiu Zhuan Fa
Keywords
Yan Nian Jiu Zhuan Fa
Medical subject headings
Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yan Nian Jiu Zhuan FaBehavioural

    Also called cognitive behavior education

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

Study groups in NCT03496961
Study groupRoleWhat they receive
Yan Nian Jiu Zhuan FaExperimentalThe 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.
Receives: Behavioral: Yan Nian Jiu Zhuan Fa
cognitive psychology educationPlacebo comparatorPsychological counseling and behavioral cognition education are conducted once a week and the rest 6 times online or by phone.
Receives: Behavioral: Yan Nian Jiu Zhuan Fa
blank controlNo interventionthis group will have no therapeutic exercises or cognitive education when other two groups receive therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months

Secondary outcomes (6)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start1 Dec 2018
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03496961
Sponsor's protocol ID
81774443
Acronym
YNJZFCFS
Status last verified
Mar 2021
First submitted
19 Mar 2018
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bakken IJ, Tveito K, Gunnes N, Ghaderi S, Stoltenberg C, Trogstad L, Haberg 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;12:167. doi: 10.1186/s12916-014-0167-5.

    PubMed 25274261

  • 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.

    PubMed 25816406

  • 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.

    PubMed 19843509

  • 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.

    PubMed 24634898

  • 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.

    PubMed 19004564

  • 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.

    PubMed 21112746

  • 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 2012 Aug 31.

    PubMed 22985998

  • Xie F, Guan C, Gu Y, You Y, Yao F. Effects of the Prolong Life With Nine Turn Method (Yan Nian Jiu Zhuan) Qigong on Brain Functional Changes in Patients With Chronic Fatigue Syndrome in Terms of Fatigue and Quality of Life. Front Neurol. 2022 Jul 13;13:866424. doi: 10.3389/fneur.2022.866424. eCollection 2022.

    PubMed 35911899

  • Xie F, You Y, Guan C, Xu J, Yao F. The Qigong of Prolong Life With Nine Turn Method Relieve Fatigue, Sleep, Anxiety and Depression in Patients With Chronic Fatigue Syndrome: A Randomized Controlled Clinical Study. Front Med (Lausanne). 2022 Jun 30;9:828414. doi: 10.3389/fmed.2022.828414. eCollection 2022.

    PubMed 35847786

  • Xie F, Guan C, Cheng Z, Yao F, You Y. Effects of the prolong life with nine turn method (Yan Nian Jiu Zhuan) Qigong on patients with chronic fatigue syndrome: study protocol for a randomized controlled trial. Ann Palliat Med. 2020 Sep;9(5):3571-3583. doi: 10.21037/apm-19-461. Epub 2020 Aug 4.

    PubMed 32787361

Questions about this trial

What is this clinical trial studying?

A study testing Yan Nian Jiu Zhuan Fa in people with Chronic Fatigue Syndromes, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fei Yao, Doc (13585975106, doctoryaofei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multidimensional Fatigue Inventory (MFI-20) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03496961, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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