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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05559814
Other study ID # Si 098/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2022

Study information

Verified date April 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date June 30, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Participants with age > 18 years who attended for colorectal cancer screening colonoscopy. 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


Related Conditions & MeSH terms


Intervention

Drug:
Intraluminal peppermint oil
Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal
Placebo
Intraluminal flushing of placebo solution through the scope during scope withdrawal

Locations

Country Name City State
Thailand Faculty of internal medicine siriraj hospital, Mahidol university Bangkok Noi Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University The Royal College of Physicians of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

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