Yishen Shujin Decoction for Fibromyalgia Syndrome

NCT07555691 | Recruiting DMC

• 1 other identifier: 2023-QNQS-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MRI; RCT; Chinese medicine

Outcome Measures

Primary Outcomes (1)

• The change of the Brief Pain Inventory (BPI) from baseline.

  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 Outcomes (9)

• The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.

  Baseline, week 2, week 4, week 8, and week 12.

• The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.

  Baseline, week 2, week 4, week 8, and week 12.

• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.

  Baseline, week 2, week 4, week 8, and week 12.

• The change of the Beck II Depression Inventory（BDI） from baseline.

  Baseline, week 2, week 4, week 8, and week 12.

• The change of the Perceived Stress Scale (PSS) from baseline.

  Baseline, week 2, week 4, week 8, and week 12.

Study Arms (2)

the placebo group

PLACEBO COMPARATOR

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 YishenShujin Decoction group

EXPERIMENTAL

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

Interventions

YishenShujin Decoction DRUG

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

the YishenShujin Decoction group

placebo DRUG

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.

the placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan Jiao: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Juan Jiao

CONTACT

010-88001132; jiao.juan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 29, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)