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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• The change of the Pain VAS score from baseline. [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]

Вторичные конечные точки (10)

• The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline. [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline. [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• The change of the Beck II Depression Inventory（BDI） from baseline. [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• The change of the Perceived Stress Scale (PSS) from baseline. [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline. [Срок оценки: Baseline, week 2, week 4, week 8, and week 12.]
• Global Impression of Change (PGIC) questionnaire evaluated at week 12. [Срок оценки: Week 12]
• Analysis of serological indicators [Срок оценки: 0, 12 weeks]
• Gut microbiota analysis [Срок оценки: 0, 12 weeks]
• Brain imaging analysis [Срок оценки: 0, 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences — Пекин

Идентификаторы

NCT: NCT07736144 · 20260708

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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