Yishen Shujin Decoction for Fibromyalgia Syndrome
ConditionFibromyalgia Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJuan Jiao
About this trial
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.
Eligibility criteria
This trial does not accept 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 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 ;
Trial design
Design model
Parallel
Treatments tested in this trial
YishenShujin Decoction
DrugPatients in the YishenShujin Decoction group received YishenShujin Decoction at 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 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: the placebo groupPlacebo comparator 1 intervention
Group B: the YishenShujin Decoction groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The change of the Brief Pain Inventory (BPI) from baseline.
The Brief Pain Inventory (BPI) evaluates the severity of pain and pain-related interference with daily functioning. The BPI total and subscale 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, week 12 and week 24Secondary 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, week 12 and week 242
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, week 12 and week 243
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, week 12 and week 244
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, week 12 and week 24Sponsors 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