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CTRI Number  CTRI/2024/10/074635 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Use of oral medication in people who undergo routine upper endoscopy to improve the efficacy of upper endoscopy 
Scientific Title of Study   Effectiveness of N acetyl cysteine and Simethicone to improve mucosal visibility during GI endoscopy-An interventional study  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSaakshi Pandit 
Designation  Junior resident 
Affiliation  Kasturba hospital,manipal 
Address  Department of general surgery,3rd floor,smt shardha Madhav Pai OPD building,Kasturba hospital,Manipal,Udupi,Karnataka,576104,India

Udupi
KARNATAKA
576104
India 
Phone  7760661033  
Fax    
Email  saakshi.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  DrSunil Krishna M 
Designation  Professor and Head of unit 
Affiliation  Kasturba hospital,manipal 
Address  Department of general surgery,3rd floor,smt shardha Madhav Pai OPD building,Kasturba hospital,Manipal,Udupi,Karnataka,576104,India

Udupi
KARNATAKA
576104
India 
Phone  9986516627  
Fax    
Email  sunil.krishna@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DrVivek Ramesh Udupi 
Designation  Assistant Professor 
Affiliation  Kasturba hospital,manipal 
Address  Department of general surgery,3rd floor,smt shardha Madhav Pai OPD building,Kasturba hospital,Manipal,Udupi,Karnataka,576104,India

Udupi
KARNATAKA
576104
India 
Phone  9643488922  
Fax    
Email  vivek.udupi@manipal.edu  
 
Source of Monetary or Material Support  
Delvin formulations-endoview 25,12th cross,St Shastri Nagar,Adyar,Chennai,tamil Nadu,India,600020 
 
Primary Sponsor  
Name  Dean,Kasturba Medical college,Manipal 
Address  First floor, administrative block, Kasturba Medical college, Manipal, Udupi, Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Delvin formulations  25,12th cross,St.shastri nagar,Adyar,Chennai,Tamil nadu,600020 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSaakshi pandit  Kasturba Hospital,Manipal  Department of general surgery,3rd floor, OPD block,Smt Sharadha Madhav Pai building,Udupi,Manipal,KArnataka
Udupi
KARNATAKA 		 7760661033

saakshi.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K299||Gastroduodenitis, unspecified, (2) ICD-10 Condition: K209||Esophagitis, unspecified, (3) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, (4) ICD-10 Condition: K23||Disorders of esophagus in diseasesclassified elsewhere, (5) ICD-10 Condition: K273||Acute peptic ulcer, site unspecified, without hemorrhage or perforation, (6) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoview  Use of solution called endoview -15ml emulsion containing 150mg Simethicone and 600mg N Acetyl Cystine given 30minutes orally before upper GI scopy,for all the patients in the trial who are willing to give consent for a period of 20months 
Comparator Agent  NIL medication  nil medication  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients undergoing upper GI endoscopy 
 
ExclusionCriteria 
Details  Acute or ongoing upper GI bleed
History of previous upper GI surgeries
Progressive dysphagia
Gastric outlet obstruction
Inadequate fasting before the procedure
Severe esophageal or gastric inflammation due to corrosive intake
Unwilling to give conssent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The total mucosal visibility score is used to asses the improvement in mucosal visibility between the two groups   20months
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced duration of procedure  20months 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Any regulatory agency or editor/reviewer of a scientific publication

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided on written request

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		  The patient will be explained about the procedure and if willing can be considered as a case and the remaining will be considered as control. Proforma filled for patients meeting the criteria in the prescribed format-consent taking. The patients are asked to drink the premedication mixed with water 20-30minutes before the procedure. Upper GI endoscopy is done and multiple images are taken from esophagus ,stomach and duodenum .The total mucosal visibility score(TMVS) ,scored from 1-4,each segment is measured as the primary outcome. The total duration of the procedure is also assessed in minutes by endoscopists as a secondary outcome measure. 
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