Mechanism Study of Yangyin Roujin Formula in the Treatment of Fibromyalgia Syndrome

NCT07736144 | Recruiting DMC

• 1 other identifier: 20260708
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). We adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic efficacy and safety in FM patients, including alleviating physical pain and common concomitant symptoms, improving physical function, and enhancing quality of life. Serum and fecal samples as well as brain MRI scans will be collected at baseline and after 12 weeks of intervention. The underlying mechanisms of this formula will be explored from multiple dimensions, including serology, gut microbiota-metabolome profiling, and central neuroimaging, so as to clarify the therapeutic advantages of Yangyin Roujin Formula for FM treatment.

Conditions

Fibromyalgia Syndrome (FM), Focusing on the Clinical Efficacy, Safety and Underlying Mechanism of Yangyin Roujin Formula for FM Patients

Keywords

Fibromyalgia Syndrome; Yangyin Roujin Formula; Randomized Controlled Trial; Herbal Medicine; Pain; Gut Microbiota; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• The change of the Pain VAS score from baseline.

  The 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 (10)

• 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 YangyinRoujin Decoction group

EXPERIMENTAL

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

Drug: Yangyin Roujin Decoction

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 YangyinRoujin 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

Interventions

Yangyin Roujin Decoction DRUG

YangyinRoujin Formula, a Chinese herbal compound formula.a dose of 2 bags each time, twice daily for 12 weeks.

the YangyinRoujin 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 YangyinRoujin 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: Yes
• 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 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.
• Patients who received antibiotics, probiotics, prebiotics, synbiotics, laxatives, or glucocorticoids within 3 months prior to enrollment; Patients with a history of severe gastrointestinal organic diseases, including inflammatory bowel disease, gastric ulcer, duodenal ulcer, intestinal polyposis, intestinal resection, chronic diarrhea or chronic constipation;

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; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: July 25, 2026
• First Posted: July 30, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)