drugset / Trial / NCT05801055

A Study to Evaluate Endoscopic Visibility of Stomach After a Combination Drink of N-acetylcysteine and Simethicone

NCT05801055

RandomizedParallel-groupDouble-blindDiagnostic

Summary

Endoscopy is the diagnostic modality for most gastroduodenal diseases. During endoscopy mucus and foam may actually interfere with the visibility of the stomach mucosa. So the mixture of mucolytic ( N-acetyl cysteine) and anti-foaming agents ( simethicone) agents may disperse the bubbles and mucus in the stomach and enhance gastric visibility. This unique combination drink given 20-30 minutes prior to endoscopy is absolutely safe. There are previous studies from India, which was retrospective study. So, we have planned to conduct this randomized controlled trial on this issue. Adult patients undergoing diagnostic endoscopy will be randomized and one group (100 patients) will be given the combination drink whereas another group 9100 patients) will undergo an endoscopy after overnight fasting only, as a placebo drink may actually hamper the endoscopic visibility. Our primary outcome, gastric visibility will be assessed using a standard visibility scoring system.

Timeline

Start
2023-04-01
Primary completion
2023-06-30
Completion
2023-06-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 600 mg Oral
Subject Simethicone Other / unclassified 150 mg Oral

Indications