Recurrent Aphthous StomatitisNCT07723612
The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa
A study testing Spirulina Tablets in people with Recurrent Aphthous Stomatitis and Mouth Ulcer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of spirulina supplementation in patients with radiation-induced oral mucositis (RIOM) receiving radiotherapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Recurrent Aphthous Stomatitis, Mouth Ulcer
- What is being tested?
- Spirulina Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
haijiao zhao
About this study
Official title: The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
This is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of spirulina supplementation in patients with radiation-induced oral mucositis (RIOM) receiving radiotherapy for head and neck cancer. Participants will be randomly assigned to receive either spirulina tablets or placebo in addition to standard oral care during radiotherapy. The primary objective is to determine whether spirulina reduces the severity of oral mucositis. Secondary outcomes include the incidence and duration of severe oral mucositis, oral pain, nutritional status, quality of life, treatment interruption, and adverse events. The findings of this study may provide evidence for an effective and safe adjunctive intervention to improve the management of radiation-induced oral mucositis and enhance the quality of life of patients undergoing radiotherapy.
Read the detailed description
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial evaluating spirulina as an adjunctive intervention for radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancer.
Radiation-induced oral mucositis is a common and clinically significant adverse effect of radiotherapy. It may cause oral pain, difficulty eating and swallowing, nutritional deterioration, reduced quality of life, and interruption of anticancer treatment. Current management is mainly supportive, and additional safe and effective interventions are needed.
Eligible participants will be randomized to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy. The study will compare the effects of spirulina and placebo on the severity, incidence, and duration of oral mucositis. Oral pain, nutritional status, quality of life, treatment compliance, radiotherapy interruption, and adverse events will also be evaluated.
The purpose of this trial is to determine whether spirulina supplementation can reduce the burden of radiation-induced oral mucositis and improve supportive care for patients undergoing radiotherapy. The safety of spirulina will be monitored throughout the study.
- Conditions
- Recurrent Aphthous Stomatitis, Mouth Ulcer
- Being tested
- Spirulina Tablets, Placebo Tablets
- Keywords
- Radiation-induced oral mucositis Recurrent aphthous stomatitis Oral ulcer Spirulina Oral microbiota Saliva biomarkers Supportive care
- Medical subject headings
- Stomatitis, Aphthous, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina TabletsDietary supplement
Also called Spirulina
Spirulina tablets will be administered at a dose of 3 g/day (6 tablets daily) from the first day of radiotherapy until completion of radiotherapy.
Placebo TabletsOther
Also called Matching placebo
Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Spirulina Group | Experimental | Participants will receive spirulina tablets (3 g/day, 6 tablets daily) in addition to standard oral care. The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy. Receives: Dietary Supplement: Spirulina Tablets |
| Placebo Group | Placebo comparator | Participants will receive matching placebo tablets (6 tablets daily) in addition to standard oral care. The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy. Receives: Other: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Clinical Characteristics of Oral Mucosal Ulcers
The incidence and clinical characteristics of oral mucosal ulcers were assessed by standardized oral examinations. The number, location, maximum diameter, estimated ulcer area, erythema, pseudomembrane or exudate, and clinical severity of ulcers were recorded throughout the study.
Measured: From Day 0 (before intervention) through Day 14, assessed daily.
Oral Pain Intensity (Visual Analog Scale, VAS)
Oral pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Measured: Day 0 (before intervention), Day 7, and Day 14.
Oral Microbiota Composition
Oral microbiota samples were collected for metagenomic sequencing to evaluate changes in microbial composition, microbial diversity, and relative abundance following the intervention.
Measured: Day 0 (before intervention), Day 7, and Day 14.
Salivary Biomarkers
Unstimulated saliva samples were collected to measure inflammatory and oxidative stress biomarkers, including IL-6, TNF-α, MDA, and SOD, to evaluate the biological effects of the intervention.
Measured: Day 0 (before intervention), Day 7, and Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Huang, PhD, Principal investigator, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723612
- Sponsor's protocol ID
- KY-2026-085
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
- ClinicalTrials.gov ID
- NCT07723612
- Acronym / sponsor ID
- KY-2026-085
- Conditions
- Recurrent Aphthous Stomatitis, Mouth Ulcer
- Keywords
- Radiation-induced oral mucositis Recurrent aphthous stomatitis Oral ulcer Spirulina Oral microbiota Saliva biomarkers Supportive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of spirulina supplementation in patients with radiation-induced oral mucositis (RIOM) receiving radiotherapy for head and neck cancer. Participants will be randomly assigned to receive either spirulina tablets or placebo in addition to standard oral care during radiotherapy. The primary objective is to determine whether spirulina reduces the severity of oral mucositis. Secondary outcomes include the incidence and duration of severe oral mucositis, oral pain, nutritional status, quality of life, treatment interruption, and adverse events. The findings of this study may provide evidence for an effective and safe adjunctive intervention to improve the management of radiation-induced oral mucositis and enhance the quality of life of patients undergoing radiotherapy.
Detailed description
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial evaluating spirulina as an adjunctive intervention for radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancer.
Radiation-induced oral mucositis is a common and clinically significant adverse effect of radiotherapy. It may cause oral pain, difficulty eating and swallowing, nutritional deterioration, reduced quality of life, and interruption of anticancer treatment. Current management is mainly supportive, and additional safe and effective interventions are needed.
Eligible participants will be randomized to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy. The study will compare the effects of spirulina and placebo on the severity, incidence, and duration of oral mucositis. Oral pain, nutritional status, quality of life, treatment compliance, radiotherapy interruption, and adverse events will also be evaluated.
The purpose of this trial is to determine whether spirulina supplementation can reduce the burden of radiation-induced oral mucositis and improve supportive care for patients undergoing radiotherapy. The safety of spirulina will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Spirulina Group | Experimental | Dietary Supplement: Spirulina TabletsParticipants will receive spirulina tablets (3 g/day, 6 tablets daily) in addition to standard oral care. The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy. |
| Placebo Group | Placebo comparator | Other: Placebo TabletsParticipants will receive matching placebo tablets (6 tablets daily) in addition to standard oral care. The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous radiotherapy to the head and neck region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina TabletsAlso: SpirulinaSpirulina tablets will be administered at a dose of 3 g/day (6 tablets daily) from the first day of radiotherapy until completion of radiotherapy. | Dietary supplement | Spirulina Group |
| Placebo TabletsAlso: Matching placeboMatching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy. | Other | Placebo Group |
Primary outcome
Incidence and Clinical Characteristics of Oral Mucosal Ulcers
Time frame: From Day 0 (before intervention) through Day 14, assessed daily.
The incidence and clinical characteristics of oral mucosal ulcers were assessed by standardized oral examinations. The number, location, maximum diameter, estimated ulcer area, erythema, pseudomembrane or exudate, and clinical severity of ulcers were recorded throughout the study.
Oral Pain Intensity (Visual Analog Scale, VAS)
Time frame: Day 0 (before intervention), Day 7, and Day 14.
Oral pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Oral Microbiota Composition
Time frame: Day 0 (before intervention), Day 7, and Day 14.
Oral microbiota samples were collected for metagenomic sequencing to evaluate changes in microbial composition, microbial diversity, and relative abundance following the intervention.
Salivary Biomarkers
Time frame: Day 0 (before intervention), Day 7, and Day 14.
Unstimulated saliva samples were collected to measure inflammatory and oxidative stress biomarkers, including IL-6, TNF-α, MDA, and SOD, to evaluate the biological effects of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xu Huang, PhD principal investigator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina Tablets in people with Recurrent Aphthous Stomatitis and Mouth Ulcer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haijiao Zhao, Master's Student (13858107163, zhaohaijiao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Clinical Characteristics of Oral Mucosal Ulcers (time frame: From Day 0 (before intervention) through Day 14, assessed daily.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.