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Ancient herbal mix may shorten radiation mouth pain in cancer patients

NCT ID NCT07339774

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a traditional Chinese herbal oral solution and mouthwash to see if they can shorten the time head and neck cancer patients suffer from severe mouth sores caused by radiation therapy. About 128 adults aged 18-65 with non-metastatic head and neck cancers will receive either the herbal treatment or a placebo alongside their radiation. The goal is to reduce the duration of painful, severe mucositis (grade 3 or higher) and improve quality of life during treatment.

What this could mean

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

Active substance
Zishui Daohuo oral liquid and Kujiu mouthwash (Chinese herbal compound)
What this could lead to
If it works, this could provide a natural option to reduce the time patients suffer from severe mouth sores during radiation therapy.
What could go wrong
This is a small, early-phase trial with only 128 participants, so results may not apply to everyone. Herbal remedies can also cause allergic reactions or interact with other treatments.

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 128 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

Dec 2026

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

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: 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Age range: 18 to 65 years old (including 18 and 65 years old); 3. Eastern Cooperative Oncology Group performance status of ≤2; 4. Radiotherapy or concurrent chemoradiotherapy is required; 5. The main organ functions well; 6. Sign informed consent. Exclusion Criteria: 1. Allergic constitution (such as those known to be allergic to two or more drugs); 2. Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy; 3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 4. Poor oral hygiene and/or severe periodontal diseases; 5. History of head and neck radiotherapy; 6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • West China Hospital

    RECRUITING

    Chengdu, Sichuan, 610041, China

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