RecruitingNot ApplicableNCT07555691

Yishen Shujin Decoction for Fibromyalgia Syndrome

A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome

Sponsor

Juan Jiao

Enrollment

100 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

fibromyalgia syndrome

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called YishenShujin Decoction and a drug called placebo for people with fibromyalgia syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYishenShujin Decoction

Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.

DRUGplacebo

The placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YishenShujin 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.