| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
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. |