Yangyin Roujin Decoction: YangyinRoujin Formula, a Chinese herbal compound formula.a dose of 2 bags each time, twice daily for 12 weeks.
placebo: The placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YangyinRoujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks.
Study summary
This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic efficacy and safety in FM patients, including alleviating physical pain and common concomitant symptoms, improving physical function, and enhancing quality of life. Serum and fecal samples as well as brain MRI scans will be collected at baseline and after 12 weeks of intervention. The underlying mechanisms of this formula will be explored from multiple dimensions, including serology, gut microbiota-metabolome profiling, and central neuroimaging, so as to clarify the therapeutic advantages of Yangyin Roujin Formula for FM treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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;
Primary outcome measure(s)
The change of the Pain VAS score from baseline. — Baseline, week 2, week 4, week 8, and week 12. The scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
Trial sites (1)
Facility
City
Region
Status
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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