Yishen Shujin Decoction for adults with fibromyalgia.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults meeting the 2016 ACR criteria for primary fibromyalgia and specific traditional Chinese medicine syndromes will be randomized to 12 weeks of Yishen Shujin Decoction or placebo, followed by 12 weeks of follow-up. The primary outcome is pain intensity measured by the Brief Pain Inventory, with secondary endpoints including the Fibromyalgia Symptom Scale, FIQR, SF-36, comorbidity measures, and safety monitoring. Structural and functional brain MRI will be obtained to explore potential mechanisms underlying any clinical effects. The trial is double-blind and placebo-controlled and is conducted at a single center in Beijing with defined exclusion criteria for major psychiatric or medical comorbidities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Juan Jiao
• Email: jiao.juan@hotmail.com
• Phone: 010-88001132

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.