Holy Basil in The Treatment of Dyspepsia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Holy basil extract
DrugHoly 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.
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Holy basilExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From baseline to the end of treatment at 28 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov