Yishen Shujin Decoction for Fibromyalgia Syndrome

Official title

A Randomized Controlled Clinical Trial and Mechanistic Investigation of Yishen Shujin Decoction for Fibromyalgia Syndrome

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• The change of the Brief Pain Inventory (BPI) from baseline. [Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24]

Secondary outcome measures (11)

• 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, week 12 and week 24]
• The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline. [Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24]
• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline. [Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24]
• The change of the Beck II Depression Inventory（BDI） from baseline. [Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24]
• The change of the Perceived Stress Scale (PSS) from baseline. [Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24]
• The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline. [Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24]
• Global Impression of Change (PGIC) questionnaire evaluated at week 12. [Time frame: Week 12.]
• Brain morphology measured by structural MRI [Time frame: 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 ).]
• Serum concentrations of inflammatory cytokines, oxidative stress biomarkers and circulating bile acids [Time frame: Before and at the end of the study ( 0, 12 weeks ).]
• Fecal relative abundance of intestinal microbiota, fecal bile acid concentration and fecal short-chain fatty acid concentration [Time frame: Before and at the end of the study ( 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 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.

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

Healthy volunteers: No

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: NCT07555691 · 2023-QNQS-09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗