Holy Basil in The Treatment of Dyspepsia

NCT ID: NCT07175272

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-12-31

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Holy basil

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

Group Type: EXPERIMENTAL

Holy basil extract

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Watcharasak Chotiyaputta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monthira Maneerattanaporn, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Somchai Leelakusolvong, MD

Role: STUDY_CHAIR

Mahidol University

Tanawat Geeratragool, MD

Role: STUDY_CHAIR

Mahidol University

Pubet Weeranawin, MD

Role: STUDY_CHAIR

Mahidol University

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Countries

Thailand

Central Contacts

Monthira Maneerattanaporn, MD

Role: CONTACT

monthira.man@mahidol.ac.th

+66 24197281

Pubet Weeranawin, MD

Role: CONTACT

Pubet.w@gmail.com

+66 24197281

Facility Contacts

Pubet Weeranawin, MD

Role: primary

pubet.w@gmail.com

+66 24197281

References

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.

Reference Type: BACKGROUND

PMID: 28400848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15234753 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22228948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31784469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32936964 (View on PubMed)

Other Identifiers

Si 643/2025

Identifier Type: -

Identifier Source: org_study_id