Holy Basil in The Treatment of Dyspepsia

NCT07175272 | Recruiting Phase 2 DMC

• 1 other identifier: Si 643/2025
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspepsia and Other Specified Disorders of Function of Stomach

Keywords

Dyspepsia; Gastritis; Holy basil

Outcome Measures

Primary Outcomes (1)

• Change in gastric mucosal inflammation score by histopathology

  Degree of gastric mucosal inflammation assessed by histopathological examination using the Updated Sydney System, measured at baseline and after 28 days of treatment.

  From baseline to the end of treatment at 28 days

Secondary Outcomes (8)

• Change in dyspeptic symptoms

  From baseline to the end of treatment at 28 days

• Change in gastroesophageal reflux symptoms

  From baseline to the end of treatment at 28 days

• Change in gastric mucosal appearance

  From baseline to end of treatment at 28 days

• Change in duodenal eosinophil count

  From baseline to end of treatment at 28 days

• Change in intragastric pH

  From baseline to end of treatment at 28 days

Study Arms (1)

Holy basil

EXPERIMENTAL

All participants will receive holy basil extract 300 mg orally once daily for 28 days.

Drug: Holy basil extract

Interventions

Holy basil extract DRUG

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.

Holy basil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (5)

• Jamshidi N, Cohen MM. The Clinical Efficacy and Safety of Tulsi in Humans: A Systematic Review of the Literature. Evid Based Complement Alternat Med. 2017;2017:9217567. doi: 10.1155/2017/9217567. Epub 2017 Mar 16.

  PMID: 28400848 RESULT

• Dharmani P, Kuchibhotla VK, Maurya R, Srivastava S, Sharma S, Palit G. Evaluation of anti-ulcerogenic and ulcer-healing properties of Ocimum sanctum Linn. J Ethnopharmacol. 2004 Aug;93(2-3):197-206. doi: 10.1016/j.jep.2004.02.029.

  PMID: 15234753 RESULT

• Pattanayak P, Behera P, Das D, Panda SK. Ocimum sanctum Linn. A reservoir plant for therapeutic applications: An overview. Pharmacogn Rev. 2010 Jan;4(7):95-105. doi: 10.4103/0973-7847.65323.

  PMID: 22228948 RESULT

• Wauters L, Talley NJ, Walker MM, Tack J, Vanuytsel T. Novel concepts in the pathophysiology and treatment of functional dyspepsia. Gut. 2020 Mar;69(3):591-600. doi: 10.1136/gutjnl-2019-318536. Epub 2019 Nov 29.

  PMID: 31784469 RESULT

• Ford AC, Moayyedi P, Black CJ, Yuan Y, Veettil SK, Mahadeva S, Kengkla K, Chaiyakunapruk N, Lee YY. Systematic review and network meta-analysis: efficacy of drugs for functional dyspepsia. Aliment Pharmacol Ther. 2021 Jan;53(1):8-21. doi: 10.1111/apt.16072. Epub 2020 Sep 16.

  PMID: 32936964 RESULT

MeSH Terms

Conditions

Dyspepsia; Gastritis

Interventions

holy basil leaf extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Monthira Maneerattanaporn, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Somchai Leelakusolvong, MD

  Mahidol University

  STUDY CHAIR

• Tanawat Geeratragool, MD

  Mahidol University

  STUDY CHAIR

• Pubet Weeranawin, MD

  Mahidol University

  STUDY CHAIR

Central Study Contacts

Monthira Maneerattanaporn, MD

CONTACT

+66 24197281; monthira.man@mahidol.ac.th

Pubet Weeranawin, MD

CONTACT

+66 24197281; Pubet.w@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single-center, open-label, single-arm clinical trial designed to evaluate the effects of holy basil extract in adults with dyspepsia. All eligible participants will receive 300 mg of holy basil extract orally once daily for 28 days. Outcomes will be assessed by comparing baseline and post-treatment measures within the same participants.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: February 13, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)