A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome
This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.
• 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.