Colonic PolypNCT05559814
Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy
A study testing Intraluminal peppermint oil in people with Colonic Polyp, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Intraluminal peppermint oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with age > 18 years who attended for colorectal cancer screening colonoscopy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, 10700
About this study
Official title: Intraluminal Peppermint Oil Can Increase Adenoma Detection Rate in Colon Cancer Screening Colonoscopy: A Double- Blinded Randomized Controlled Trial
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
- Colonic Polyp
- Being tested
- Intraluminal peppermint oil, Placebo
- Keywords
- Peppermint oil, Adenoma detection rate, Colonic peristalsis
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraluminal peppermint oilDrug
Intraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal
PlaceboDrug
Intraluminal flushing of placebo solution through the scope during scope withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Peppermint oil | Experimental | 1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween) Receives: Drug: Intraluminal peppermint oil |
| Placebo | Placebo comparator | Placebo solution 50ml(Simethicone plus tween) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate(ADR)
Number of adenoma per total participants who were colonoscopy in both groups
Measured: During colonoscopy
Secondary outcomes (5)
Adenoma per posititive participants(APP)
Number of aenama in patients who had found at least one adenoma in both groups
Measured: During colonoscopy
Colonic peristalsis grading
Percentage of colonic peristalsis grade 0 and 1 in peppermint oil group in both groups
Measured: During colonoscopy
Time of polyps resection
Time of polypectomy per polyp in both groups
Measured: During colonoscopy
Intravenous anti-spasmodic agents
Percentage of intravenous anti-spasmodic agents in both groups
Measured: During colonoscopy
Adeverse events
Total number of adverse events in both groups
Measured: 24 hours after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Mar 2021
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Physicians of Thailand
- Responsible party
- Principal investigator, Uayporn Kaosombatwattana, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559814
- Sponsor's protocol ID
- Si 098/2021
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraluminal Peppermint Oil Can Increase Adenoma Detection Rate in Colon Cancer Screening Colonoscopy: A Double- Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05559814
- Acronym / sponsor ID
- Si 098/2021
- Conditions
- Colonic Polyp
- Keywords
- Peppermint oil, Adenoma detection rate, Colonic peristalsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- The Royal College of Physicians of Thailand
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Sep 2022 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peppermint oil | Experimental | Drug: Intraluminal peppermint oil1.6% peppermint oil solution 50 ml(Peppermint oil plus simethicone and tween) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution 50ml(Simethicone plus tween) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with age > 18 years who attended for colorectal cancer screening colonoscopy.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Intraluminal peppermint oilIntraluminal flushing of peppermint oil solution through the scope channel during the scope withdrawal | Drug | Peppermint oil |
| PlaceboIntraluminal flushing of placebo solution through the scope during scope withdrawal | Drug | Placebo |
Primary outcome
Adenoma detection rate(ADR)
Time frame: During colonoscopy
Number of adenoma per total participants who were colonoscopy in both groups
5 secondary outcomes
Adenoma per posititive participants(APP)
Time frame: During colonoscopy
Colonic peristalsis grading
Time frame: During colonoscopy
Time of polyps resection
Time frame: During colonoscopy
Intravenous anti-spasmodic agents
Time frame: During colonoscopy
Adeverse events
Time frame: 24 hours after colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraluminal peppermint oil in people with Colonic Polyp, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 5 Apr 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate(ADR) (time frame: During colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2023.