Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia Syndrome, Yangyin Roujin Formula, Randomized Controlled Trial, Herbal Medicine, Pain, Gut Microbiota, Magnetic Resonance Imaging
Brief summary
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.
Interventions
DRUGYangyin Roujin Decoction
YangyinRoujin Formula, a Chinese herbal compound formula.a dose of 2 bags each time, twice daily for 12 weeks.
DRUGplacebo
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.
Sponsors
Juan Jiao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of the Pain VAS score from baseline. | Baseline, week 2, week 4, week 8, and week 12. | The scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline | Baseline, week 2, week 4, week 8, and week 12. | 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. |
| The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline. | Baseline, week 2, week 4, week 8, and week 12. | 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. |
| The change of the Beck II Depression Inventory（BDI） from baseline. | Baseline, week 2, week 4, week 8, and week 12. | 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. |
| The change of the Perceived Stress Scale (PSS) from baseline. | Baseline, week 2, week 4, week 8, and week 12. | 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. |
| The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline. | Baseline, week 2, week 4, week 8, and week 12. | 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). |
| Global Impression of Change (PGIC) questionnaire evaluated at week 12. | 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). |
| Analysis of serological indicators | 0, 12 weeks | 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. |
| Gut microbiota analysis | 0, 12 weeks | 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. |
| Brain imaging analysis | 0, 12 weeks | 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. |
Countries
China
Contacts
CONTACTJuan Jiao
Outcome results
None listed