A Phase 2/3 interventional study of Holy basil extract in Dyspepsia and Other Specified Disorders of Function of Stomach, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Mahidol University · Phase 2/3, Interventional, and Treatment
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:
Participants will:
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 27 is below the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All participants will receive holy basil extract 300 mg orally once daily for 28 days.
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.
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.
Time frame: From baseline to the end of treatment at 28 days
Change in dyspeptic symptoms
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.
Time frame: From baseline to the end of treatment at 28 days
Change in gastroesophageal reflux symptoms
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.
Time frame: From baseline to the end of treatment at 28 days
Change in gastric mucosal appearance
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.
Time frame: From baseline to end of treatment at 28 days
Change in duodenal eosinophil count
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.
Time frame: From baseline to end of treatment at 28 days
Change in intragastric pH
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.
Time frame: From baseline to end of treatment at 28 days
Change in esophageal acid exposure time
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.
Time frame: From baseline to end of treatment at 28 days
Change in serum interleukin-6 (IL-6) levels
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.
Time frame: From baseline to end of treatment at 28 days
Incidence of adverse events
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.
Time frame: From baseline to end of treatment at 28 days
Plan to share: No — To protect participant confidentiality and comply with institutional and regulatory requirements, no IPD will be shared unless with reasonable request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Holy basil leaf extract