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Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Primary Purpose

Colonic Polyp

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Intraluminal peppermint oil

Placebo

About this trial

This is an interventional screening trial for Colonic Polyp focused on measuring Peppermint oil, Adenoma detection rate, Colonic peristalsis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty of internal medicine siriraj hospital, Mahidol university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peppermint oil

Placebo

Arm Description

1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween)

Placebo solution 50ml(Simethicone plus tween)

Outcomes

Primary Outcome Measures

Adenoma detection rate(ADR)

Number of adenoma per total participants who were colonoscopy in both groups

Secondary Outcome Measures

Adenoma per posititive participants(APP)

Number of aenama in patients who had found at least one adenoma in both groups

Colonic peristalsis grading

Percentage of colonic peristalsis grade 0 and 1 in peppermint oil group in both groups

Time of polyps resection

Time of polypectomy per polyp in both groups

Intravenous anti-spasmodic agents

Percentage of intravenous anti-spasmodic agents in both groups

Adeverse events

Total number of adverse events in both groups

Full Information

NCT ID

NCT05559814

First Posted

September 26, 2022

Last Updated

April 3, 2023

Sponsor

Mahidol University

Collaborators

The Royal College of Physicians of Thailand

1. Study Identification

Unique Protocol Identification Number

NCT05559814

Brief Title

Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Official Title

Intraluminal Peppermint Oil Can Increase Adenoma Detection Rate in Colon Cancer Screening Colonoscopy: A Double- Blinded Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

The Royal College of Physicians of Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Polyp

Keywords

Peppermint oil, Adenoma detection rate, Colonic peristalsis

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peppermint oil

Arm Type

Experimental

Arm Description

1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo solution 50ml(Simethicone plus tween)

Intervention Type

Drug

Intervention Name(s)

Intraluminal peppermint oil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intraluminal flushing of placebo solution through the scope during scope withdrawal

Primary Outcome Measure Information:

Title

Adenoma detection rate(ADR)

Description

Number of adenoma per total participants who were colonoscopy in both groups

Time Frame

During colonoscopy

Secondary Outcome Measure Information:

Title

Adenoma per posititive participants(APP)

Description

Number of aenama in patients who had found at least one adenoma in both groups

Time Frame

During colonoscopy

Title

Colonic peristalsis grading

Description

Percentage of colonic peristalsis grade 0 and 1 in peppermint oil group in both groups

Time Frame

During colonoscopy

Title

Time of polyps resection

Description

Time of polypectomy per polyp in both groups

Time Frame

During colonoscopy

Title

Intravenous anti-spasmodic agents

Description

Percentage of intravenous anti-spasmodic agents in both groups

Time Frame

During colonoscopy

Title

Adeverse events

Description

Total number of adverse events in both groups

Time Frame

24 hours after colonoscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Faculty of internal medicine siriraj hospital, Mahidol university

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

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Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

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