Holy Basil in The Treatment of Dyspepsia

Not Applicable

Not yet recruiting

• Conditions: Dyspepsia and Other Specified Disorders of Function of Stomach
• Interventions: Drug: Holy basil extract

• Registration Number: NCT07175272
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in gastric mucosal inflammation score by histopathology	From baseline to the end of treatment at 28 days	Degree of gastric mucosal inflammation assessed by histopathological examination using the Updated Sydney System, measured at baseline and after 28 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in dyspeptic symptoms	From baseline to the end of treatment at 28 days	Dyspeptic symptoms such as epigastric pain, fullness, bloating, and nausea will be assessed using the Leeds Dyspepsia Questionnaire. Total and individual symptom scores will be recorded at baseline and after 28 days of treatment, and changes will be analyzed.
Change in gastroesophageal reflux symptoms	From baseline to the end of treatment at 28 days	Symptoms of gastroesophageal reflux disease, including heartburn and regurgitation, will be evaluated using the Frequency Scale for the Symptoms of GERD (FSSG). Scores will be compared between baseline and post-treatment assessments.
Change in gastric mucosal appearance	From baseline to end of treatment at 28 days	Endoscopic appearance of the gastric mucosa will be assessed using the Modified Lanza Score (MLS) during upper endoscopy. The severity of gastric mucosal injury will be graded, and scores will be compared before and after treatment.
Change in duodenal eosinophil count	From baseline to end of treatment at 28 days	Biopsies from the duodenum will be examined histologically to determine intraepithelial eosinophil counts. The mean number of eosinophils per high-power field will be compared between baseline and after 28 days of holy basil extract.
Change in esophageal acid exposure time	From baseline to end of treatment at 28 days	Esophageal acid exposure will be assessed by 24-hour ambulatory pH monitoring. Mean pH values and time spent below pH thresholds will be recorded and compared between baseline and after treatment.
Change in intragastric pH	From baseline to end of treatment at 28 days	Gastric acid levels will be assessed by 24-hour ambulatory intragastric pH monitoring. Mean pH values and time spent below pH thresholds will be recorded and compared between baseline and after treatment.
Change in serum interleukin-6 (IL-6) levels	From baseline to end of treatment at 28 days	Blood samples will be collected to measure serum IL-6 levels as a marker of systemic inflammation. Baseline values will be compared to those after 28 days of treatment.
Incidence of adverse events	From baseline to end of treatment at 28 days	All adverse events and side effects reported by participants or observed by investigators will be collected, categorized by severity and relationship to study medication, and summarized.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand