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Ancient herbal formula may soothe radiation burns in the mouth

NCT ID NCT07692997

Symptom relief Sponsor: Nanfang Hospital, Southern Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether a traditional Chinese herbal drink called Sancai Fengsui Decoction can help heal painful mouth sores caused by radiation therapy for head and neck cancer. About 126 adults who have developed moderate to severe mouth sores after radiation will receive either the herbal drink or a placebo for two weeks. Researchers will measure pain relief and healing of the sores to see if the herbal treatment improves recovery and quality of life.

What this could mean

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

Active substance
Sancai Fengsui Decoction (Chinese herbal compound)
What this could lead to
If effective, this herbal treatment could offer a new way to reduce mouth pain and speed recovery from radiation-induced mouth sores, improving quality of life for head and neck cancer patients.
What could go wrong
This is a Phase 2 trial with only 126 participants, so results are preliminary. The herbal mixture may not outperform placebo, and individual responses may vary.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 126 people

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

Expected to start

Aug 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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Meets the diagnostic criteria for RTOM, with severity classified according to the RTOG grading system; * Voluntarily participates in this study and signs the informed consent form; * Age between 18 and 65 years; * Histopathologically diagnosed with non-metastatic head and neck malignancy; * Has received radiotherapy or concurrent chemoradiotherapy; * ECOG performance status score: 0-2; * Adequate major organ function. * Exclusion Criteria: * Patients with severe heart, lung, liver, kidney, digestive system, hematopoietic system, or nervous system diseases; acute infectious diseases; autoimmune diseases; HIV; diabetes mellitus with poor blood glucose control; or any other serious condition that, in the investigator's judgment, may increase the risk of the study, interfere with study execution or result analysis, or make the subject unsuitable for enrollment for other reasons; * Pregnant or breastfeeding women; * Allergic constitution; * Patients with severe psychiatric disorders, or a history of alcohol or drug abuse; * Participation in another clinical trial within the past 3 months; * Subjects deemed unsuitable for participation in this clinical study by the investigator.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced oral mucositis head and neck cancer Head and Neck Neoplasms stomatitis

As listed by the trial registrant

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

Head and neck cancer Oral mucositis of rtog grade greater than 1 Radiation-induced oral mucositis (RTOM)

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.