Actively Recruiting
Yishen Shujin Decoction for Fibromyalgia Syndrome
Led by Juan Jiao · Updated on 2026-04-29
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Yishen Shujin Decoction for Fibromyalgia Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary fibromyalgia meeting 2016 American College of Rheumatology 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 currently on fibromyalgia treatments or not treated for more than 1 month
- Signed informed consent form
You will not qualify if you...
- Severe depression or anxiety
- Serious cardiovascular, cerebrovascular, liver, kidney, hematopoietic system diseases, or thrombotic diseases
- Pregnant or breastfeeding women
- Allergic to treatment ingredients
- Severe pain from other diseases such as 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 like brain tumor, stroke, epilepsy, traumatic brain injury, or multiple sclerosis
- Incompatible implants such as pacemakers, defibrillators, certain aneurysm clips, cochlear implants, or neurostimulators
- Presence of metal foreign bodies in the body including dentures, intraorbital fragments, or shrapnel
- Claustrophobia
AI-Screening
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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
CONTACT
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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