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Holy Basil in The Treatment of Dyspepsia

NCT07175272 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-03-24

No results posted yet for this study

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

Conditions

  • Dyspepsia and Other Specified Disorders of Function of Stomach

Interventions

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Monthira Maneerattanaporn, MD · Mahidol University

  • Somchai Leelakusolvong, MD · Mahidol University

  • Tanawat Geeratragool, MD · Mahidol University

  • Pubet Weeranawin, MD · Mahidol University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175272 on ClinicalTrials.gov