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Herbal pills aim to heal diabetic wounds faster

NCT ID NCT07258381

Disease control Sponsor: Peking University Third Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether Mailuo Shutong Pills, a Chinese herbal medicine, can help heal diabetic wounds in people with a specific traditional Chinese medicine pattern (damp-heat toxin accumulation). About 56 adults with diabetes and a wound between 1 and 40 cm² will be randomly assigned to get the pills or a blank control on top of standard wound care. The main goal is to see if the wound shrinks more with the pills.

What this could mean

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

Active substance
Mailuo Shutong Pills (a Chinese herbal medicine blend)
What this could lead to
If it works, this could provide a new add-on treatment to help diabetic wounds heal faster.
What could go wrong
This is a small, early exploratory trial with only 56 people. The pills may not speed healing for everyone, and results may not apply to all diabetic wounds.

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 56 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 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 80 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: * a confirmed diagnosis of type 1 or type 2 diabetes mellitus; * the type of wound is an ulcer, with an ulcer area ranging from 1 to 40cm ²; * the wound etiology is diabetic, mainly abnormalities in blood glucose, resulting in poor or prolonged healing and requiring standard wound therapy; * The traditional Chinese medicine diagnosis is Damp-Heat Toxin Accumulation Syndrome; * voluntary participation in the study and signing of an informed consent form. Exclusion Criteria: * Diagnosis of a Cold Pattern according to Traditional Chinese Medicine (TCM) differentiation, manifested as: pale, enlarged, and tender tongue with a white, moist or glossy coating; pallor; pale lips; aversion to cold with a preference for warmth; and loose stools. * Pregnancy or lactation. * Presence of severe, uncorrected systemic diseases, such as acute myocardial infarction, heart failure, hepatitis, shock, or respiratory failure. Active bleeding within the wound that prevents the implementation of standard wound care. * Severe laboratory abnormalities: serum albumin \< 20 g/L; hemoglobin \< 60 g/L; or platelet count \< 50 × 10⁹/L. * Diagnosis of advanced malignant tumor. * Active phase of an autoimmune disease. * History of hypersensitivity to Mailuo Shutong Pills or Mailuo Shutong Granules. * Inability to cooperate with the study procedures or presence of psychiatric disorders. * Any other condition considered by the investigator as a clear, unmodifiable factor adversely affecting wound healing, making the candidate unsuitable for the study or unable to comply with the study requirements.

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As listed by the trial registrant

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

Chronic wound care Diabetic wound

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