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CTRI Number  CTRI/2025/09/095015 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To validate a Hindi translated version of an established tool (RENZI score) for evaluation of constipation patients in indian population. 
Scientific Title of Study   Validation of RENZI score for obstructed defecation syndrome to Indian population. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pawan Lal 
Designation  Director Professor Surgery 
Affiliation  Maulana Azad Medical College 
Address  Room 229, Department of Surgery Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  9968604405  
Fax    
Email  info@pawanlal.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pawan Lal 
Designation  Director Professor Surgery 
Affiliation  Maulana Azad Medical College 
Address  Room 229, Department of Surgery Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  9968604405  
Fax    
Email  info@pawanlal.com  
 
Details of Contact Person
Public Query  
Name  Dr Pawan Lal 
Designation  Director Professor Surgery 
Affiliation  Maulana Azad Medical College 
Address  Room 229, Department of Surgery Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  9968604405  
Fax    
Email  info@pawanlal.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Maulana Azad Medical Collehe 
Address  Bahadurshah Zafar Marg, New Delhi 110002 (India) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pawan Lal  Maulana Azad Medical College  Room 229, B L Taneja Block, Maulana Azad Medical College, Bahadurshah Zafar Marg New Delhi 110002 (India)
Central
DELHI 		 9968604405

info@pawanlal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. with constipation for more than 30 days 
 
ExclusionCriteria 
Details  1. Diabetes
2. Patients with diagnosed tuberculosis
3. Patients with inflammatory bowel diseases
4. Debilitated bedridden patients
5. Neurological conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Validity and reliability of Hindi Renzi Score   at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of ODS in Hindi-speaking patients with chronic constipation  at baseline 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   01/10/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [info@pawanlal.com].

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 30-09-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Despite its simplicity, no validated Hindi version of the Renzi score exists, limiting its utility among Hindi-speaking patients in India. This study aims to address that gap.

 
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