Last reviewed · How we verify
NCT05801055
A Study to Evaluate Endoscopic Visibility of Stomach After a Combination Drink of N-acetylcysteine and Simethicone
Phase 3 trial testing Evaluation of gastric visibility following the combination drink of N-acetyle cysteine and simethocone in Gastric Disease in 200 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 200 |
| Start date | 1 April 2023 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across India |
Drugs / interventions tested
- Evaluation of gastric visibility following the combination drink of N-acetyle cysteine and simethocone
Conditions studied
- Gastric Disease — all drugs for Gastric Disease →
Sponsor
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Who can join
Adults 18 to 75, any sex, with Gastric Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05801055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Sanjay Gandhi Postgraduate Institute of Medical Sciences trials
Trials by the same sponsor.
- NCT06853834 — Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients With Suspected Sarcoidosis · NA · recruiting
- NCT05946967 — Colon Transit Study for Chronic Constipation Assessment and Therapy by Biofeedback With and Without TENS · NA · unknown
- NCT05898048 — CMV Reactivation in Acute Necrotizing Pancreatitis · completed
- NCT06274970 — PaThERAS: ERAS Protocols in Thyroid & Parathyroid Surgery · NA · completed
- NCT05535439 — Diagnostic Yield & Specimen Adequacy of Flex 19 G vs 22 G EBUS Needle - A Randomized Controlled Trial · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05801055 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Last refreshed: 6 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05801055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing