Dyspepsia and Other Specified Disorders of Function of StomachPhase 2/3NCT07175272
Holy Basil in The Treatment of Dyspepsia
A Phase 2/3 study testing Holy basil extract in people with Dyspepsia and Other Specified Disorders of Function of Stomach, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia and Other Specified Disorders of Function of Stomach
- What is being tested?
- Holy basil extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- 13 Feb 2026to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Pubet Weeranawin, MD, +66 24197281, pubet.w@gmail.com
Monthira Maneerattanaporn, MD
About this study
Official title: Evaluation of The Effect of Holy Basil in The Treatment of Patients With Dyspepsia
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:
Read more
- 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
Read the 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.
- Being tested
- Holy basil extract
- Keywords
- Dyspepsia, Gastritis, Holy basil
- Medical subject headings
- Dyspepsia, Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holy basil extractDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Holy basil | Experimental | All participants will receive holy basil extract 300 mg orally once daily for 28 days. Receives: Drug: Holy basil extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the end of treatment at 28 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to end of treatment at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start13 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dyspepsia and Other Specified Disorders of Function of StomachStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, open-label, single-arm clinical trial designed to evaluate the effects of holy basil extract in adults with dyspepsia. All eligible participants will receive 300 mg of holy basil extract orally once daily for 28 days. Outcomes will be assessed by comparing baseline and post-treatment measures within the same participants.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Watcharasak Chotiyaputta, Mahidol University
- Investigators
- Monthira Maneerattanaporn, MD, Principal investigator, Mahidol UniversitySomchai Leelakusolvong, MD, Study chair, Mahidol UniversityTanawat Geeratragool, MD, Study chair, Mahidol UniversityPubet Weeranawin, MD, Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175272
- Sponsor's protocol ID
- Si 643/2025
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant confidentiality and comply with institutional and regulatory requirements, no IPD will be shared unless with reasonable request.
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.
PubMed 28400848Dharmani 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.
PubMed 15234753Pattanayak 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.
PubMed 22228948Wauters 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.
PubMed 31784469Ford 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.
PubMed 32936964
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Holy Basil in The Treatment of Patients With Dyspepsia
- ClinicalTrials.gov ID
- NCT07175272
- Acronym / sponsor ID
- Si 643/2025
- Keywords
- Dyspepsia, Gastritis, Holy basil
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, open-label, single-arm clinical trial designed to evaluate the effects of holy basil extract in adults with dyspepsia. All eligible participants will receive 300 mg of holy basil extract orally once daily for 28 days. Outcomes will be assessed by comparing baseline and post-treatment measures within the same participants.
| Arm | Type | Receives |
|---|---|---|
| Holy basil | Experimental | Drug: Holy basil extractAll participants will receive holy basil extract 300 mg orally once daily for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holy basil extractHoly 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. | Drug | Holy basil |
Primary outcome
Change in gastric mucosal inflammation score by histopathology
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 28400848Jamshidi 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.
- Results publication: PubMed 15234753Dharmani 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.
- Results publication: PubMed 22228948Pattanayak 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.
- Results publication: PubMed 31784469Wauters 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.
- Results publication: PubMed 32936964Ford 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.
- Individual participant dataSharing planned: No. To protect participant confidentiality and comply with institutional and regulatory requirements, no IPD will be shared unless with reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monthira Maneerattanaporn, MD principal investigator
Mahidol University
Somchai Leelakusolvong, MD study chair
Mahidol University
Tanawat Geeratragool, MD study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Holy basil extract in people with Dyspepsia and Other Specified Disorders of Function of Stomach, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monthira Maneerattanaporn, MD (+66 24197281, monthira.man@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastric mucosal inflammation score by histopathology (time frame: From baseline to the end of treatment at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175272, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.