ColonoscopyNCT07501962
Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate
A study testing Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. and Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. in people with Colonoscopy, run by The First Affiliated Hospital of Zhengzhou University.
Trial summary
In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. and Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years, regardless of gender;
- Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
- Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
- Voluntarily signed informed consent and able to cooperate with completing study-related assessments.
Who cannot join
- Allergy to menthol, cyclodextrin, or related substances;
- History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
- Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
- Pregnant or lactating women;
- Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
- Psychiatric disorders or cognitive impairment that prevent cooperation with the study;
- History of contraindications to colonoscopy or serious adverse reactions during previous procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study
In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol relaxes intestinal smooth muscle and alleviates spasm symptoms by antagonizing L-type calcium channels on the smooth muscle cell membrane, thereby reducing calcium influx. Furthermore, it exhibits local analgesic effects and can attenuate visceral hypersensitivity. Some studies suggest that oral or topical administration of peppermint oil preparations may improve intestinal spasm during colonoscopy, highlighting its potential utility in digestive endoscopy procedures. Nevertheless, current research on the spasmolytic efficacy and safety of menthol solution when administered via endoscopic irrigation during colonoscopy remains limited, and high-quality clinical trials are urgently needed for validation. This study aims to investigate the effectiveness and safety of menthol solution in relieving intestinal spasm, thereby providing scientific evidence for optimizing colonoscopy procedures.
- Conditions
- Colonoscopy
- Being tested
- Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone., Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone.Drug
Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension.
Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.Drug
Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension.
| Study group | Role | What they receive |
|---|---|---|
| Menthol group | Experimental | Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. Receives: Drug: Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. |
| placebo group | Placebo comparator | Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. Receives: Drug: Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intestinal spasm
Intestinal spasm score:
Score 1 (Excellent): No spasm; the lumen opening is greater than or equal to two-thirds of the maximum diameter.
Score 2 (Moderate): Moderate spasm; the lumen opening is less than two-thirds of the maximum diameter.
Score 3 (Poor): Severe spasm; the oral-side lumen cannot be visualized.
The maximum diameter is defined as the diameter of the intestinal lumen when fully distended.
Spasm incidence: The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group.
Measured: Day 0
adenoma detection rate (ADR)
ADR = (Number of patients with at least one adenomatous polyp detected / Total number of patients in the group) × 100%.
Pathological diagnosis was used as the gold standard.
Measured: Day 0
Secondary outcomes (2)
Spasm inhibition rate
The percentage of patients whose lumen opening exceeded two-thirds of the maximum diameter within 30 seconds after water injection irrigation, relative to the total number of patients in the group.
Measured: Day 0
Polyp detection rate (PDR)
PDR = (Number of patients with at least one polyp detected / Total number of patients in the group) × 100%.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianning Yao, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501962
- Sponsor's protocol ID
- 2026-KY-0394-001
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study
- ClinicalTrials.gov ID
- NCT07501962
- Acronym / sponsor ID
- 2026-KY-0394-001
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (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.
In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol relaxes intestinal smooth muscle and alleviates spasm symptoms by antagonizing L-type calcium channels on the smooth muscle cell membrane, thereby reducing calcium influx. Furthermore, it exhibits local analgesic effects and can attenuate visceral hypersensitivity. Some studies suggest that oral or topical administration of peppermint oil preparations may improve intestinal spasm during colonoscopy, highlighting its potential utility in digestive endoscopy procedures. Nevertheless, current research on the spasmolytic efficacy and safety of menthol solution when administered via endoscopic irrigation during colonoscopy remains limited, and high-quality clinical trials are urgently needed for validation. This study aims to investigate the effectiveness and safety of menthol solution in relieving intestinal spasm, thereby providing scientific evidence for optimizing colonoscopy procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menthol group | Experimental | Drug: Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone.Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. |
| placebo group | Placebo comparator | Drug: Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years, regardless of gender;
- Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
- Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
- Voluntarily signed informed consent and able to cooperate with completing study-related assessments.
Key exclusion criteria (7 listed)
- Allergy to menthol, cyclodextrin, or related substances;
- History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
- Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
- Pregnant or lactating women;
- Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
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 |
|---|---|---|
| Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone.Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension. | Drug | Menthol group |
| Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension. | Drug | placebo group |
Primary outcome
Incidence of intestinal spasm
Time frame: Day 0
Intestinal spasm score: Score 1 (Excellent): No spasm; the lumen opening is greater than or equal to two-thirds of the maximum diameter. Score 2 (Moderate): Moderate spasm; the lumen opening is less than two-thirds of the maximum diameter. Score 3 (Poor): Severe spasm; the oral-side lumen cannot be visualized. The maximum diameter is defined as the diameter of the intestinal lumen when fully distended. Spasm incidence: The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group.
adenoma detection rate (ADR)
Time frame: Day 0
ADR = (Number of patients with at least one adenomatous polyp detected / Total number of patients in the group) × 100%. Pathological diagnosis was used as the gold standard.
2 secondary outcomes
Spasm inhibition rate
Time frame: Day 0
Polyp detection rate (PDR)
Time frame: Day 0
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 30 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. and Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. in people with Colonoscopy, run by The First Affiliated Hospital of Zhengzhou University.
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 4 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Jianning Yao (13733183434, rjyy@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intestinal spasm (time frame: Day 0). The study lists 2 primary outcomes in all. 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 30 Mar 2026.