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Herbal granules could ease painful breast lumps without surgery

NCT ID NCT07512648

Disease control Sponsor: Caigang Liu 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a Chinese herbal medicine called Sanyong Jiedu Granules can safely shrink breast lumps caused by non-lactational mastitis (inflammation not related to breastfeeding). About 210 women aged 20–50 with lump-type mastitis will receive the granules or a placebo. The main goal is to see how many women have their lumps completely or partially disappear.

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 210 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

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

20 to 50 years

Sex

Female participants only

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: * Women aged 20-50 years (inclusive) who are not in lactation or pregnancy (as confirmed * Meeting the diagnostic criteria for non-lactational mastitis * In the mass phase of non-lactational mastitis, with no surface ulceration or only minor ulceration or microabscesses, but without sinus tract or fistula formation * Diagnosed as "exuberant heat-toxin syndrome" in Traditional Chinese Medicine (TCM) syndrome differentiation * nformed consent obtained and signed by the subject Exclusion Criteria: * Patients with intolerance or poor compliance to the investigational drug, or known hypersensitivity to any component of this regimen * Patients with clinically or laboratory-confirmed severe cardiac, hepatic, or renal dysfunction, or those with severe complications, active infections, persistent fever, severe bleeding tendency, or hematopoietic abnormalities * Patients diagnosed with breast cancer by pathological biopsy * Confirmed as tuberculous granuloma by pathogen examination * Pregnant and lactating women, as well as women of childbearing age who are fertile but unwilling to use effective contraception throughout the trial period * A clear history of neurological or psychiatric disorders, including epilepsy or dementia;Suspected or confirmed history of alcohol or drug abuse;Participants deemed unsuitable for the study by the investigators

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Conditions

The condition(s) this trial relates to.

granulomatous mastitis mastitis

As listed by the trial registrant

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

Granulomatous lobular mastitis Plasmacytic mastitis

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

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022, China

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