This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
YangyinRoujin Formula, a Chinese herbal compound formula.a dose of 2 bags each time, twice daily for 12 weeks.
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.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe 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.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.
This scale consists of two subdomains to evaluate the overall severity of fibromyalgia according to the ACR fibromyalgia diagnostic criteria. The Widespread Pain Index (WPI) assesses the extent and diffuseness of body pain, with scores ranging from 0 to 19. Higher scores indicate more widespread, diffuse pain distribution across the body. The Symptom Severity Score (SSS) evaluates the severity of core accompanying fibromyalgia symptoms, with total scores ranging from 0 to 12. Higher scores represent greater severity of general somatic and associated symptomatic burden.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Beck II Depression Inventory（BDI） from baseline.
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Time frame: Baseline, week 2, week 4, week 8, and week 12.
The change of the Perceived Stress Scale (PSS) from baseline.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
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.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Time frame: Baseline, week 2, week 4, week 8, and week 12.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 \[very much improved\] to 7 \[very much worse).
Time frame: Week 12
Analysis of serological indicators
A total of 10 mL fasting peripheral venous blood will be collected from subjects before and after treatment. After standing for serum separation, serum samples will be aliquoted and stored in a -80°C ultra-low temperature freezer for unified laboratory testing of serological indicators.
Time frame: 0, 12 weeks
Gut microbiota analysis
Approximately 50 mL fresh fecal samples will be collected before and after treatment, transferred into sterile enzyme-free sampling tubes, snap-frozen in liquid nitrogen, and preserved at -80°C. Subsequent 16S rRNA sequencing analysis of gut microbiota will be performed uniformly.
Time frame: 0, 12 weeks
Brain imaging analysis
Standardized brain magnetic resonance imaging (MRI) scans will be performed on all subjects before and after treatment with consistent scanner models and scanning parameters. Raw DICOM imaging data will be archived for subsequent structural and functional brain analysis.
Time frame: 0, 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.