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New treatment option for Fibromyalgia Syndrome
Official title Yishen Shujin Decoction for Fibromyalgia Syndrome
ClinicalTrials.gov ID: NCT07555691
What this study is testing
What is YishenShujin Decoction?
YishenShujin Decoction is an investigational medicine, given as an once-daily, being studied as a potential treatment for fibromyalgia syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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 ；
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.