CompletedNCT05559814Updated Apr 5, 2023

Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

An interventional study of Intraluminal peppermint oil and Placebo in Colonic Polyp, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by Mahidol University · Not applicable, Interventional, and Screening

From the registry’s dates

Registered 1 year 6 months after the study started (first participant enrolled Mar 2021, registered Sep 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 404
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study summary

This is a prospective randomized placebo-controlled trial to evaluate the efficacy of peppermint oil spraying into the colonic lumen through the scope channel during screening colonoscopy. The primary outcome is to compare the colonic peristalsis between peppermint oil and placebo. The secondary outcomes compare the procedural time, polyp detection rate, adenoma detection rate, and adverse events.

Conditions studied

Colonic Polyp

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Keywords

Peppermint oil, Adenoma detection rate, Colonic peristalsis

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 404 is above the median of 250 across 412 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Participants with age > 18 years who attended for colorectal cancer screening colonoscopy.

Exclusion criteria

Exclusion Criteria:

Participants who had been colectomy
Participants who diagnosed of inflammatory bowel disease or polyposis syndrome.
Participants who had been took anti-spasmosic drugs prior to colonoscopy within 24 hours (Anticholibergic/Antimuscarinic : Hyoscine(Buscopan®), Dicyclomine(Berclomine®) or Smooth muscle relaxant : Mebeverine(Duspatin®,Colofac®), Pinaverium bromide(Dicetel®), Alverine(Meteospasmyl®), Peppermint oil(Colpermin®))
Participants with Prothrombin time > 3 second ULN, INR > 1.5 or Platelet \< 50,000.
Pregnancy or breast feeding
Participants who cannot consent.
Participants who had history of peppermint oil allergy.

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 404 participants (actual)

Study arms

Experimental
Peppermint oil
1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween)
Drug: Intraluminal peppermint oil
Placebo comparator
Placebo
Placebo solution 50ml(Simethicone plus tween)
Drug: Placebo

Interventions

DrugIntraluminal peppermint oil
Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal
DrugPlacebo
Intraluminal flushing of placebo solution through the scope during scope withdrawal

What researchers measure

Primary outcomes

Adenoma detection rate(ADR)
Number of adenoma per total participants who were colonoscopy in both groups
Time frame: During colonoscopy

Secondary outcomes

Adenoma per posititive participants(APP)
Number of aenama in patients who had found at least one adenoma in both groups
Time frame: During colonoscopy
Colonic peristalsis grading
Percentage of colonic peristalsis grade 0 and 1 in peppermint oil group in both groups
Time frame: During colonoscopy
Time of polyps resection
Time of polypectomy per polyp in both groups
Time frame: During colonoscopy
Intravenous anti-spasmodic agents
Percentage of intravenous anti-spasmodic agents in both groups
Time frame: During colonoscopy
Adeverse events
Total number of adverse events in both groups
Time frame: 24 hours after colonoscopy

Study locations

1 site

Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok 10700, Thailand

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05559814
Lead sponsor: Mahidol University
Collaborators: The Royal College of Physicians of Thailand
Responsible party: Uayporn Kaosombatwattana (Department of Medicine, Siriraj Hospital, Mahidol university, Mahidol University) — Principal investigator
First posted: Sep 29, 2022
Start date: Mar 1, 2021
Primary completion: May 31, 2022
Completion: Jun 30, 2022
Last update: Apr 5, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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