Randomized Trial of Yishen Shujin Decoction for Treating Fibromyalgia Syndrome with Brain Imaging Study

What this Trial Is About

Researchers are evaluating the effects of YishenShujin Decoction, a traditional herbal prescription, in adults with fibromyalgia syndrome FM. This 24-week randomized, double-blind, placebo-controlled study includes a 12-week treatment phase followed by a 12-week follow-up. The main goal is to assess changes in pain intensity using the Brief Pain Inventory BPI. Secondary measures include symptom scales, impact questionnaires, quality of life assessments, and monitoring of FM-related conditions. Brain MRI scans will also be used to explore underlying mechanisms. Participants are randomly assigned to receive either YishenShujin Decoction or a placebo, both given as granules at a dose of 2 bags twice daily for 12 weeks. The placebo is designed to mimic the decoction in color, taste, texture, and smell but contains only one-tenth of the original dose. The study involves brain imaging and analysis of blood and fecal samples collected before and after the treatment period to evaluate inflammatory markers, oxidative stress, bile acids, and gut microbiota. Throughout the study, participants will complete questionnaires and symptom assessments at baseline and several time points up to 24 weeks. Brain structural and functional MRI scans are performed before treatment and at week 12. Safety is closely monitored during the intervention and follow-up. Participants are expected to attend scheduled visits for assessments and sample collection to measure the effectiveness and safety of the treatment over the full 24-week period.

Yishen Shujin Decoction for Fibromyalgia Syndrome