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Ancient herbal remedy put to the test for fibromyalgia sufferers

NCT ID NCT07555691

Symptom relief Sponsor: Juan Jiao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests whether a traditional Chinese herbal formula called Yishen Shujin Decoction can reduce pain and improve quality of life in people with fibromyalgia. One hundred adults with fibromyalgia will receive either the herbal formula or a placebo for 12 weeks, and researchers will track pain levels, symptoms, and brain changes using MRI. The goal is to see if this herbal treatment offers real relief beyond a placebo effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Yishen Shujin Decoction (herbal formula)
What this could lead to
If it works, this could provide a new, natural option for managing fibromyalgia pain and related symptoms.
What could go wrong
This is an early-stage trial with only 100 people. The placebo effect is strong in pain studies, and the herbal formula may not outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, China

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