NCT06410430 Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis
| NCT ID | NCT06410430 |
| Status | Unknown |
| Phase | — |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2024-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-01-31 with a primary completion date of 2024-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To investigate the mechanism by Ba-Duan-Jin in the treatment of fibromyalgia. Twenty eligible fibromyalgia patients were selected, and were trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. The evaluation points were 0, 4, 8, and 12 weeks. The change of pain Visual Analogue Score (VAS) and tener point count (TPC) post-treatment were evaluated. And blood, feces, and brain fMRI were collected from the patients at 0 and 12 weeks to compare the changes in gut microbiota, metabolites, and brain function networks before and after the intervention with the 16SrRNA sequencing, targeted metabolomics, and real-time Quantitative Polymerase Chain Reaction (PCR).
Eligibility Criteria
Inclusion Criteria: * Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia or 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria; * Be over 18 years of age; * Female; * Right-handedness; * Sign informed consent. Exclusion Criteria: * be less than 40mm of pain VAS score; * had received any treatments for fibromyalgia or probiotic bacteria within 2 weeks; * had received antibiotics within 4 weeks; * had practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months; * had severe depression or anxiety; * pregnancy or planned pregnancy within the study period; * had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis; * patients with a history of head trauma, cerebral infarction or cerebral haemorrhage * contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06410430 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06410430 currently recruiting?
NCT06410430 is currently listed as "Unknown" and is not actively enrolling. Check ClinicalTrials.gov for the latest status updates.
Where is the NCT06410430 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06410430 clinical trial?
NCT06410430 is sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. The trial plans to enroll 40 participants.
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