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Holy Basil in The Treatment of Dyspepsia

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMahidol University
NCT07175272 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate whether holy basil extract can reduce gastric inflammation and improve symptoms in adult patients with dyspepsia. The main questions it aims to answer are: * Does holy basil extract reduce gastric mucosal inflammation as measured by histopathology? * Does holy basil extract improve dyspeptic symptoms, endoscopic findings, gastric pH, duodenal eosinophil counts, and systemic inflammation (serum IL-6)? Participants will: * Take 300 mg of holy basil extract orally once daily for 28 days * Complete symptom questionnaires and diaries during treatment * Undergo upper endoscopy with biopsy and intragastric pH monitoring before and after treatment * Provide blood samples for inflammatory marker measurement * Be monitored for safety and adverse events

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participants aged 18 years and older. * Presence of dyspeptic symptoms, assessed by the Leeds Dyspepsia Questionnaire with a score of at least 5 or higher. Exclusion Criteria: * Presence of Helicobacter pylori infection. * Diagnosis of peptic ulcer or erosive esophagitis Los Angeles Classification grade B or greater. * Use of acid-suppressant therapy including proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) that cannot be discontinued at least 2 weeks prior enrolment and during the study period. * Use of mucosal protective agents, such as rebamipide, sucralfate, or irsogladine that cannot be discontinued at least 4 weeks prior enrolment and during the study period. * History of gastric cancer or duodenal cancer. * Previous upper gastrointestinal surgery. * Current pregnancy or lactation. * Known allergic to the medicine.
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What it tests

  • Holy basil extract
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Where

1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Thailand
🤝 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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