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

Inclusion Criteria6

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 Criteria12

Patients with severe depression or anxiety ;
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.
Contraindications include:
History of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc.
Incompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc.
Presence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc.
Claustrophobia.

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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.