Actively Recruiting
Randomized Controlled Trial and Mechanistic Study of Yishen Shujin Decoction for Fibromyalgia Syndrome
Led by Juan Jiao · Updated on 2026-04-29
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of YishenShujin Decoction, a recognized herbal treatment, in adults with fibromyalgia syndrome (FM) through a 24-week randomized, double-blind, placebo-controlled clinical trial. This study aims to assess the formula's impact on pain intensity using the Brief Pain Inventory (BPI) and other symptom scales, while also exploring brain structure and function through MRI to understand the treatment's mechanisms. Safety profiles will be closely monitored throughout the study. Participants are randomly assigned to receive either the YishenShujin Decoction or a placebo that mimics the active treatment in appearance and taste. Both groups take two bags twice daily for 12 weeks, followed by a 12-week follow-up period. Brain MRI scans are conducted before and after the intervention to evaluate changes in brain morphology and functional connectivity. Throughout the study, participants undergo regular assessments at baseline, weeks 2, 4, 8, and 12, including pain and symptom scales, quality of life questionnaires, fatigue, depression, and perceived stress measures. The primary outcome focuses on changes in pain intensity. Safety and global impressions of change are also recorded. The total study duration for each participant is 24 weeks, including treatment and follow-up phases.
CONDITIONS
Brief Title
Yishen Shujin Decoction for Fibromyalgia Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with primary fibromyalgia according to American College of Rheumatology 2016 criteria
- Traditional Chinese Medicine syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency
- Age between 18 and 75 years old
- Pain visual analog scale score of 4 or higher
- Not using fibromyalgia treatments or programs for more than 1 month
- Signed informed consent form
You will not qualify if you...
- Severe depression or anxiety
- Serious diseases affecting cardiovascular, cerebrovascular, liver, kidney, hematopoietic systems, or thrombotic diseases
- Pregnant or breastfeeding women
- Allergy to any treatment ingredients
- Severe pain caused by other diseases like diabetic pain or postherpetic neuralgia
- Recent participation in clinical trials for the same condition
- Male, right-handed, or contraindications for MRI scanning
- History of neurological diseases such as brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis
- Incompatible implants like pacemakers, defibrillators, certain aneurysm clips, cochlear implants, neurostimulators
- Presence of metallic foreign bodies like dentures, intraorbital fragments, or shrapnel
- Claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive Yishen Shujin Decoction or placebo granules twice daily.
Visits at baseline, week 2, week 4, week 8, and week 12 for assessments
Trial Site Locations
Total: 1 location
1
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Juan Jiao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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