NCT07175272 Holy Basil in The Treatment of Dyspepsia
| NCT ID | NCT07175272 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mahidol University |
| Condition | Dyspepsia and Other Specified Disorders of Function of Stomach |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 27 participants in total. It began in 2026-02-13 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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.
Contact & Investigator
Monthira Maneerattanaporn, MD
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT07175272 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dyspepsia and Other Specified Disorders of Function of Stomach. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07175272 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07175272 currently recruiting?
Yes, NCT07175272 is actively recruiting participants. Contact the research team at monthira.man@mahidol.ac.th for enrollment information.
Where is the NCT07175272 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT07175272 clinical trial?
NCT07175272 is sponsored by Mahidol University. The principal investigator is Monthira Maneerattanaporn, MD at Mahidol University. The trial plans to enroll 27 participants.