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The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa

RecruitingNAAges 18 Years - 100 YearsAllThe Fourth Affiliated Hospital of Zhejiang Univer…
NCT07723612 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Spirulina Tablets
  • Placebo Tablets
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Where

1 site
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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