Yishen Shujin Decoction for Fibromyalgia Syndrome

April 21, 2026 updated by: Juan Jiao

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: the placebo group
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.
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.
Experimental: the YishenShujin Decoction group
Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the Brief Pain Inventory (BPI) from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.
The Brief Pain Inventory (BPI) evaluates the severity of pain and pain-related interference with daily functioning. The BPI total and subscale scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
Baseline, week 2, week 4, week 8, and week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Time Frame: Week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
Week 12.
The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.

This scale consists of two subdomains to evaluate the overall severity of fibromyalgia according to the ACR fibromyalgia diagnostic criteria.

The Widespread Pain Index (WPI) assesses the extent and diffuseness of body pain, with scores ranging from 0 to 19. Higher scores indicate more widespread, diffuse pain distribution across the body.

The Symptom Severity Score (SSS) evaluates the severity of core accompanying fibromyalgia symptoms, with total scores ranging from 0 to 12. Higher scores represent greater severity of general somatic and associated symptomatic burden.
Baseline, week 2, week 4, week 8, and week 12.
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Baseline, week 2, week 4, week 8, and week 12.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Baseline, week 2, week 4, week 8, and week 12.
The change of the Beck II Depression Inventory（BDI） from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Baseline, week 2, week 4, week 8, and week 12.
The change of the Perceived Stress Scale (PSS) from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Baseline, week 2, week 4, week 8, and week 12.
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
Time Frame: Baseline, week 2, week 4, week 8, and week 12.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Baseline, week 2, week 4, week 8, and week 12.
Brain morphology measured by structural MRI
Time Frame: Before and at the end of the study ( 0, 12 weeks ).
To compare the changes in brain structure and morphology in patients with fibromyalgia before and after treatment by structural MRI. The images were acquired by a Siemens 3.0T Skyra scanner (Siemens; Munich, Germany) using fast spoiled gradient-echo sequence. Images contain whole brain, grey matter, white matter, atlas-based regions of interest for the patient group and healthy controls. The structural MRI images were processed with CAT 12 software (Version12.7, r1700). In detail, the voxel-based morphometry pipeline includes initial and refined voxel-based processing.
Before and at the end of the study ( 0, 12 weeks ).
Brain functional connectivity measured by function MRI
Time Frame: Before and at the end of the study ( 0, 12 weeks ).
To compare the changes in connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by function MRI. The scanning sequence is set up under the guidance of an imaging professional, while ensuring that the participants undergo the MRI scans with their eyes closed but awake; head movements do not exceed 1.5 mm in translation in any direction and 1.5° in rotation in any direction.
Before and at the end of the study ( 0, 12 weeks ).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Jiao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-QNQS-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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