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Recruiting NCT07736144

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

No phase Interventional Fibromyalgia Syndrome (FM), Focusing on the Clinical Efficacy, Safety and Underlying Mechanism of Yangyin Roujin Formula for FM Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yangyin Roujin Decoction, placebo.
Who it may be relevant to
Registry conditions: Fibromyalgia Syndrome (FM), Focusing on the Clinical Efficacy, Safety and Underlying Mechanism of Yangyin Roujin Formula for FM Patients. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Mechanism of Yangyin Roujin Formula in Fibromyalgia Syndrome: A Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Yangyin Roujin Decoction
    YangyinRoujin Formula, a Chinese herbal compound formula.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 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.

Primary outcome measures

  • The change of the Pain VAS score from baseline. [Time frame: Baseline, week 2, week 4, week 8, and week 12.]
Secondary outcome measures (10)
  • 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.]
  • The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline [Time frame: 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 change of the Beck II Depression Inventory（BDI） from baseline. [Time frame: 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 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.]
  • Global Impression of Change (PGIC) questionnaire evaluated at week 12. [Time frame: Week 12]
  • Analysis of serological indicators [Time frame: 0, 12 weeks]
  • Gut microbiota analysis [Time frame: 0, 12 weeks]
  • Brain imaging analysis [Time frame: 0, 12 weeks]

Eligibility criteria

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 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences — Beijing

Identifiers

NCT: NCT07736144 · 20260708

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗