Holy Basil in The Treatment of Dyspepsia

Official title

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

Overview

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.

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 da

Primary outcome measures

• Change in gastric mucosal inflammation score by histopathology [Time frame: From baseline to the end of treatment at 28 days]

Secondary outcome measures (8)

• Change in dyspeptic symptoms [Time frame: From baseline to the end of treatment at 28 days]
• Change in gastroesophageal reflux symptoms [Time frame: From baseline to the end of treatment at 28 days]
• Change in gastric mucosal appearance [Time frame: From baseline to end of treatment at 28 days]
• Change in duodenal eosinophil count [Time frame: From baseline to end of treatment at 28 days]
• Change in intragastric pH [Time frame: From baseline to end of treatment at 28 days]
• Change in esophageal acid exposure time [Time frame: From baseline to end of treatment at 28 days]
• Change in serum interleukin-6 (IL-6) levels [Time frame: From baseline to end of treatment at 28 days]
• Incidence of adverse events [Time frame: From baseline to end of treatment at 28 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 1 center

• Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok Noi

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07175272 · Si 643/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗