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Blue-Green algae vs. painful mouth sores: a trial puts spirulina to the test

NCT ID NCT07723612

Disease control Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether spirulina, a dietary supplement made from blue-green algae, can reduce the severity and pain of recurrent aphthous ulcers (canker sores). Forty adults with active mouth ulcers will receive either spirulina tablets or a placebo for a set period. Researchers will track ulcer size, pain levels, and changes in oral bacteria and inflammatory markers to see if spirulina offers any benefit over standard care.

What this could mean

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

Active substance
Spirulina tablets (a dietary supplement from blue-green algae)
What this could lead to
If spirulina works, it could offer a natural, safe option to reduce pain and speed healing of recurrent mouth ulcers.
What could go wrong
This is a small early-stage trial with only 40 participants. Spirulina is a supplement, not a drug, so its effects may be modest or no better than placebo.

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 40 people

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

Started

Jun 2026

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 100 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: * Adults aged 18 years or older. * Patients with radiation-induced oral mucositis (RIOM), recurrent aphthous stomatitis (RAS), or other clinically diagnosed oral ulcers, confirmed by clinical examination. * Presence of at least one clinically active oral ulcer at the time of enrollment. * Able to understand the study procedures and provide written informed consent. * Willing and able to comply with all study procedures, follow-up visits, and assessments. Exclusion Criteria: * Previous radiotherapy to the head and neck region. * Known allergy or hypersensitivity to spirulina or its components. * Severe hepatic, renal, cardiovascular, or other uncontrolled systemic diseases. * Pregnancy or breastfeeding. * Participation in another interventional clinical trial during the study period. * Any condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.

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Conditions

The condition(s) this trial relates to.

aphthous stomatitis canker sore Oral Ulcer

As listed by the trial registrant

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

Mouth ulcer Recurrent aphthous stomatitis

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

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Contacts and locations

Locations

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Yiwu, Zhejiang, 322000, China

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