NCT07175272

Holy Basil in The Treatment of Dyspepsia

Evaluation of The Effect of Holy Basil in The Treatment of Patients With Dyspepsia

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Functional dyspepsia is a common condition that causes chronic upper abdominal discomfort, bloating, and early satiety in the absence of structural disease. Conventional therapies such as acid suppression medications or prokinetics provide incomplete symptom relief for many patients, and newer approaches are needed. Increasing evidence suggests that mucosal inflammation, duodenal eosinophilia, and systemic immune activation may play a key role in the disorder. Holy basil (Ocimum sanctum), or tulsi, is a traditional medicinal herb with anti-inflammatory and gastroprotective properties demonstrated in preclinical studies. It has been shown to reduce gastric acid secretion, increase mucus production, and decrease inflammatory cell infiltration in animal models, but its clinical effects in patients with dyspepsia have not been studied. This single-center, open-label trial will enroll 27 adults with dyspeptic symptoms at Siriraj Hospital, Mahidol University. All participants will receive 300 mg of holy basil extract once daily for 28 days. The primary outcome is the change in gastric mucosal inflammation assessed by histopathology before and after treatment. Secondary outcomes include improvement in dyspeptic and reflux symptoms, reduction in duodenal eosinophil counts, changes in gastric mucosal appearance on endoscopy, alterations in intragastric pH, and changes in serum interleukin-6 levels as a marker of systemic inflammation. Safety and tolerability will also be evaluated. Participants will undergo baseline evaluations, including symptom assessment, blood tests, 24-hour pH monitoring, and upper endoscopy with biopsy. These procedures will be repeated at the end of the 28-day treatment period. Weekly monitoring will include review of symptoms, adverse events, and medication compliance. The study is designed to provide clinical evidence on whether holy basil extract can improve gastric inflammation and relieve symptoms in patients with dyspepsia. Results may support its role as a novel herbal-based therapy for functional dyspepsia.

Conditions

• Dyspepsia and Other Specified Disorders of Function of Stomach

Interventions

Type	Name	Description
DRUG	Holy basil extract	Holy basil extract (Ocimum sanctum) will be provided as an oral capsule formulation. Each capsule contains 300 mg of standardized holy basil extract with defined amounts of active compounds including ursolic acid (≥0.10 mg) and rosmarinic acid (≥0.50 mg). Participants will be instructed to take one capsule once daily for 28 consecutive days. The capsules will be dispensed in blister packs, with labeling according to clinical trial regulatory requirements. Participants will be asked to record daily intake in a study diary, and compliance.

Timeline

• Start date: 2026-02-13
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-09-16
• Last updated: 2026-03-24

Locations

1 site across 1 country: Thailand