Holy basil (tulsi) to treat dyspepsia
Official title: Evaluation of The Effect of Holy Basil in The Treatment of Patients With Dyspepsia
Run by Mahidol University · NCT07175272 · Data updated 2026-11-12
This study will test whether taking 300 mg of holy basil extract once daily for 28 days can reduce stomach inflammation and improve symptoms in adults with dyspepsia.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 27 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Status | Recruiting |
| Started | February 13, 2026 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07175272 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with chronic dyspeptic symptoms and a Leeds Dyspepsia Questionnaire score ≥5 who can discontinue acid-suppressant and certain mucosal-protective medications and have no H. pylori infection are the intended candidates.
✕Probably not a fit
Patients with active H. pylori infection, peptic ulcer disease, significant erosive esophagitis, prior upper GI surgery, current pregnancy or lactation, or those unable to stop excluded medications are unlikely to receive benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, open-label Phase 2/3 trial at Siriraj Hospital will enroll 27 adults with dyspepsia who will receive 300 mg of holy basil extract daily for 28 days and be monitored for safety. Participants undergo upper endoscopy with biopsy and intragastric pH monitoring before and after treatment, complete symptom questionnaires and diaries, and provide blood samples for serum IL-6. The primary outcome is change in gastric mucosal inflammation on histopathology, with secondary outcomes including symptom scores, duodenal eosinophil counts, endoscopic mucosal appearance, intragastric pH, and systemic inflammation. Key exclusions include H. pylori infection, peptic ulcer or significant erosive esophagitis, recent inability to stop acid-suppressant or mucosal-protective medications, prior gastric surgery, pregnancy, or known allergy to the medicine.
Why it matters
Potential benefit: If successful, holy basil could offer a low-cost, well-tolerated herbal option to reduce gastric inflammation and improve dyspeptic symptoms.
How similar studies have gone: Preclinical animal studies have demonstrated anti-inflammatory and gastroprotective effects of holy basil, but clinical data in patients with dyspepsia are currently lacking.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand Recruiting
Study contacts
- Principal investigator: Monthira Maneerattanaporn, MD — Mahidol University
- Study coordinator: Monthira Maneerattanaporn, MD
- Email: monthira.man@mahidol.ac.th
- Phone: +66 24197281
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.