Mechanism Study of Yangyin Roujin Formula in the Treatment of Fibromyalgia Syndrome
ConditionFibromyalgia Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJuan Jiao
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Yangyin Roujin Decoction
DrugYangyinRoujin Formula, a Chinese herbal compound formula.a dose of 2 bags each time, twice daily for 12 weeks.
placebo
DrugThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: the YangyinRoujin Decoction groupExperimental treatment 1 intervention
Group B: the placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The 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.Secondary outcomes
1
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 12.2
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 12.3
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 12.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Juan Jiao
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor institution
Source ClinicalTrials.gov