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Yishen Shujin Decoction for Fibromyalgia Syndrome

NCT07555691 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Fibromyalgia Syndrome

Interventions

DRUG

YishenShujin Decoction

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

DRUG

placebo

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.

Sponsors & Collaborators

  • Juan Jiao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555691 on ClinicalTrials.gov