YishenShujin Decoction: Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.
placebo: The 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 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 ;
* 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.
Contraindications include:
History of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc.
Incompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc.
Presence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc.
Claustrophobia.
Primary outcome measure(s)
The change of the Brief Pain Inventory (BPI) from baseline. — Baseline, week 2, week 4, week 8, week 12 and week 24 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.
Trial sites (1)
Facility
City
Region
Status
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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