Yangyin Roujin Formula for Fibromyalgia: Does it help pain and function?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial examines the safety and therapeutic potential of Yangyin Roujin Decoction in adults with fibromyalgia. The study collects serum, fecal samples, and brain MRI to explore possible mechanisms, including gut microbiota and neuroimaging changes, over 12 weeks. Participants are adults with fibromyalgia meeting ACR 2016 criteria, experiencing pain, and not currently on FM medications. Outcomes focus on pain reduction, physical function, and quality of life, alongside biomarker and imaging analyses. The trial is conducted at Guang'anmen Hospital in Beijing with lead sponsor Juan Jiao.

Why it matters

Who can join: the full rules

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 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.

Patients who received antibiotics, probiotics, prebiotics, synbiotics, laxatives, or glucocorticoids within 3 months prior to enrollment; Patients with a history of severe gastrointestinal organic diseases, including inflammatory bowel disease, gastric ulcer, duodenal ulcer, intestinal polyposis, intestinal resection, chronic diarrhea or chronic constipation;

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.