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CTRI Number  CTRI/2024/05/067724 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring Lifestyle Changes and relation with Chronic Constipation 
Scientific Title of Study   Assessing the effect of changing the lifestyle in patient with chronic constipation (longitudinal observational study) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Dineshrao Ingale 
Designation  Post Graduate Student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Clinical Research Department, School of Allied Health and Sciences Datta Meghe Institute of Higher Education and Research university Sawangi Wardha 442001

Wardha
MAHARASHTRA
442001
India 
Phone  7887917587  
Fax    
Email  sakshiingale2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijendra Kirnake 
Designation  Professor HOD DNB ,Gastroenterology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Gastroenterology Datta Meghe Institute of Higher Education and research Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7768901370  
Fax    
Email  drvijendrakirnake@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijendra Kirnake 
Designation  Professor HOD DNB ,Gastroenterology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Gastroenterology Datta Meghe Institute of Higher Education and research Sawangi Meghe Wardha


MAHARASHTRA
442001
India 
Phone  7768901370  
Fax    
Email  drvijendrakirnake@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi Wardha India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi, Wardha India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sakshi Dineshrao Ingale  Acharya Vinoba Bhave Rural Hospital.  Department of Gastroenterology AVBRH Sawangi,Wardha
Wardha
MAHARASHTRA 
7887917587

sakshiingale2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  • Age- 45 to 75
• Gender- Male/Female
• Patients: Chronic Constipation
 
 
ExclusionCriteria 
Details 
• General Population.
• Young generation not allowed.
• Children are not allowed.
• Other type of constipation is not allowed
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective of this research is to aware the chronic constipation patients about the healthy lifestyle.  6 month  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="194"
Sample Size from India="194" 
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)   16/07/2024 
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="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 - NO
Brief Summary  

Abstract: It is stated that difficult and infrequent stool passage is a common complication of chronic constipation. Persistent and widespread, chronic constipation affects a large number of patients globally, posing a financial burden and leading to a high level of healthcare utilization. The term "constipation" refers to a state in which bowel movements are infrequent and accompanied by other symptoms such as abdominal bloating, hard consistency of stools, prolonged or unsuccessful attempts to defecate, excessive straining, and a sense of incomplete evacuation. The first line of treatment for primary constipation, regardless of the cause, involves dietary and lifestyle modifications, such as promoting sufficient intake of fluids and fiber, consistent exercise, and dietary adjustments. Individual lifestyle decisions have a substantial impact on stool consistency, gastrointestinal motility, and overall bowel function. variables like eating patterns, physical patterns etc. One of the most common gastrointestinal conditions found in Western countries’ clinical practices is constipation. Because nearly 20% of people have this illness, constipation is a major cause of medical visits. Constipation has a complex and multifactorial pathophysiology that requires consideration of a number of factors, including genetic predisposition, lifestyle choices, psychological distress, and disruptions in colonic transit. Constipation diagnosis is challenging and necessitates a complete and precise examination. A nonpharmacological approach, education of the patient about the importance of lifestyle changes like diet and sport activity state, are the first line of therapy. In case of ineffective treatment, pharmacological treatments such as laxatives, secretagogues, serotonergic agonists, and many other medications should be induced.

 
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