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Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate 440

Not yet recruiting
Clinical Trial NCT07501962 is an interventional study for Colonoscopy and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 440 participants. Led by The First Affiliated Hospital of Zhengzhou University, this study is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
Brief 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. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol rel...Show More
Official Title

Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate: An Efficacy and Safety Study

Conditions
Colonoscopy
Other Study IDs
  • 2026-KY-0394-001
NCT ID Number
NCT07501962
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
440
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMenthol group
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.
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 Comparatorplacebo 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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
Day 0
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Day 0
Polyp detection rate (PDR)
PDR = (Number of patients with at least one polyp detected / Total number of patients in the group) × 100%.
Day 0
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. Age between 18 and 75 years, regardless of gender;
  2. Scheduled to undergo colonoscopy (for screening, diagnostic, or follow-up purposes);
  3. Adequate bowel preparation quality (Boston Bowel Preparation Scale score ≥ 6);
  4. Voluntarily signed informed consent and able to cooperate with completing study-related assessments.

  1. Allergy to menthol, cyclodextrin, or related substances;
  2. History of severe intestinal diseases (such as ulcerative colitis, Crohn's disease, intestinal perforation, intestinal obstruction, intestinal tumors, etc.);
  3. Presence of severe dysfunction of vital organs such as the heart, liver, kidneys, or lungs, or coagulation disorders;
  4. Pregnant or lactating women;
  5. Use of anticholinergic drugs, calcium channel blockers, or other spasmolytic agents within one week prior to the examination;
  6. Psychiatric disorders or cognitive impairment that prevent cooperation with the study;
  7. History of contraindications to colonoscopy or serious adverse reactions during previous procedures.
The First Affiliated Hospital of Zhengzhou University logoThe First Affiliated Hospital of Zhengzhou University
Study Responsible Party
Jianning Yao, Principal Investigator, Chief Physician, The First Affiliated Hospital of Zhengzhou University
Study Central Contact
Contact: Jianning Yao, 13733183434, [email protected]
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