Yishen Shujin Decoction for adults with fibromyalgia.
A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome
This 24-week randomized, double-blind, placebo-controlled trial will test whether Yishen Shujin Decoction reduces pain and improves symptoms in adults with fibromyalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07555691 on ClinicalTrials.gov |
What this trial studies
Adults meeting the 2016 ACR criteria for primary fibromyalgia and specific traditional Chinese medicine syndromes will be randomized to 12 weeks of Yishen Shujin Decoction or placebo, followed by 12 weeks of follow-up. The primary outcome is pain intensity measured by the Brief Pain Inventory, with secondary endpoints including the Fibromyalgia Symptom Scale, FIQR, SF-36, comorbidity measures, and safety monitoring. Structural and functional brain MRI will be obtained to explore potential mechanisms underlying any clinical effects. The trial is double-blind and placebo-controlled and is conducted at a single center in Beijing with defined exclusion criteria for major psychiatric or medical comorbidities.
Who should consider this trial
Good fit: Adults aged 18–75 with primary fibromyalgia by 2016 ACR criteria, pain VAS ≥4, matching the specified TCM syndromes, not currently receiving FM treatments (or off them >1 month), and willing to consent are the ideal candidates.
Not a fit: Patients with severe depression or anxiety, major cardiovascular/cerebrovascular or hepatic/renal/hematologic disease, pregnancy or lactation, allergies to the ingredients, other causes of severe pain, or recent participation in similar trials are unlikely to benefit.
Why it matters
Potential benefit: If successful, the formula could provide a well-tolerated herbal option to reduce pain and improve function in people with fibromyalgia.
How similar studies have performed: Some small trials of Chinese herbal formulas have suggested symptom improvements in fibromyalgia, but high-quality, replicated evidence is limited and the approach is not yet firmly established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with primary fibromyalgia who met the FM classification criteria established by the American College of Rheumatology in 2016. * TCM syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency. * aged 18 years old and above, 75 years old and below. * pain VAS score ≥ 4. * not taking the treatment of FM drugs or not using the treatment of FM program for more than 1 month. * Sign the informed consent. Exclusion Criteria: * Patients with severe depression or anxiety ; * patients with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases and thrombotic diseases ; * Lactating or pregnant women ; * patients with allergy to therapeutic ingredients ; * patients with severe pain caused by other diseases ( such as diabetic pain or postherpetic neuralgia ) ; * patients who have recently participated in clinical trials of the same indications ； * Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning. Contraindications include: History of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc. Incompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc. Presence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc. Claustrophobia.
Where this trial is running
Beijing, Beijing Municipality
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Juan Jiao
- Email: jiao.juan@hotmail.com
- Phone: 010-88001132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.