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Ancient herbal formula put to the test against fibromyalgia pain

NCT ID NCT07708948

Symptom relief Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study investigates whether Tongluo Kaibi Tablets, a traditional Chinese herbal medicine, can reduce pain and improve quality of life in people with fibromyalgia syndrome. The trial enrolls 150 adults aged 18 to 75 who meet fibromyalgia criteria and have significant pain. Participants receive either the herbal tablets or the standard drug pregabalin for 8 weeks, and researchers measure changes in pain levels and symptom impact.

What this could mean

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

Active substance
Tongluo Kaibi Tablet, a Chinese herbal medicine made from eight herbs, compared with pregabalin
What this could lead to
If successful, this could provide a new, well-studied herbal option for managing fibromyalgia pain and symptoms.
What could go wrong
This is a relatively small Phase 4 trial, and the herbal treatment may not prove more effective than existing options like pregabalin. Results may not apply to all patients.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

150 people

The number who actually took part.

Started

Jan 2024

Finished

Mar 2026

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: * Aged 18 to 75 years at the time of informed consent acquisition, regardless of gender; * Meet the 2016 fibromyalgia classification criteria established by the American College of Rheumatology; * Score ≥4 on the Visual Analogue Scale for Pain (Pain VAS) at screening; * Agree to receive 8 weeks of treatment and related examinations, and sign the informed consent form; * No medication for fibromyalgia, or the types and dosages of medications for fibromyalgia have remained stable for at least 2 weeks. Exclusion Criteria: * Have a medical history or confirmed diagnosis of any of the following conditions during screening: severe cardiovascular and cerebrovascular diseases; combined diabetes, malignant tumors, hematological diseases, inflammatory arthritis or other severe progressive systemic diseases; other psychiatric disorders leading to inability or unwillingness to cooperate with the trial; * Any laboratory test result before screening meets the following criteria: liver and renal function tests show ALT or AST \> 2 times the upper limit of normal (ULN), or creatinine (Cr) \> 1.2 times ULN (refer to the normal reference range of the laboratory at each study center); other clinically significant abnormal laboratory parameters judged by investigators to disqualify subjects from enrollment; * Allergic constitution, or hypersensitivity to the investigational product Tongluo Kaibi Tablets, pregabalin capsules, excipients or similar ingredients; Suspected or confirmed history of alcohol or substance abuse; * Pregnant or lactating women, women planning pregnancy in the near future, or those unwilling to adopt contraceptive measures; * Receiving Tongluo Kaibi Tablets at enrollment; * Participation in any other clinical trial within 3 months prior to enrollment; * Any other conditions judged by investigators to render the subject unsuitable for this clinical trial.

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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

Contacts and locations

Locations

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

    Beijing, Beijing Municipality, 100053, China

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