| CTRI Number |
CTRI/2024/02/062596 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study predictors of endoscopic healing in patients of Ulcerative Colitis on clinical remission |
|
Scientific Title of Study
|
Evaluation of predictors of endoscopic healing in patients of Ulcerative Colitis on clinical remission |
| 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. Nikhil Sirohi |
| Designation |
Senior Resident |
| Affiliation |
Delhi University |
| Address |
Academic Block Second Floor, Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research , Jawahar Lal Nehru Marg
New Delhi
DELHI
110002
India |
| Phone |
7665565530 |
| Fax |
|
| Email |
nikhilsirohi1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashok Dalal |
| Designation |
Associate Professor |
| Affiliation |
Delhi University |
| Address |
Academic Block Second Floor, Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research , Jawahar Lal Nehru Marg
New Delhi
DELHI
110002
India |
| Phone |
7665565530 |
| Fax |
|
| Email |
ashok.dalal83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Sirohi |
| Designation |
Senior Resident |
| Affiliation |
Delhi University |
| Address |
Academic Block Second Floor, Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research , Jawahar Lal Nehru Marg
New Delhi
DELHI
110002
India |
| Phone |
7665565530 |
| Fax |
|
| Email |
nikhilsirohi1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute Of Postgraduate Medical Education And Research |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Institute Of Postgraduate Medical Education And Research |
| Address |
Jawahar Lal Nehru Marg
New Delhi-110002 |
| Type of Sponsor |
Government 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 |
| Dr Nikhil Sirohi |
Govind Ballabh Pant Institute Of Postgraduate Medical Education And Research |
Department of Gastroenterology , Academic Block , Second Floor
New Delhi
DELHI |
7665565530
nikhilsirohi1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K51||Ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ulcerative colitis based on standard clinical , endoscopic and histological criteria and in clinical remission (Partial Mayo score less than equal to 3) from past 6 months
|
|
| ExclusionCriteria |
| Details |
Patients who are pregnant
with any other malignancy or autoimmune disease
patients with serious complications such as infections , intestinal tuberculosis and ischemia
previous surgical resection or diagnosis of IBD unspecified |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the predictors related to endoscopic healing in patients of ulcerative colitis on clinical remission |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the clinical predictors of endoscopic healing in patients of ulcerative colitis on clinical remission
to find out the biochemical predictors of endoscopic healing in patients of ulcerative colitis on clinical remission
to find out the radiological predictors of endoscopic healing in patients of ulcerative colitis on clinical remission
to find out the histological predictors of endoscopic healing in patients of ulcerative colitis on clinical remission |
At the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Our s is a cross sectional single center study in which patients with diagnosed Ulcerative colitis on clinical remission for 6 months which will be calculated using partial mayo score less than equal to 3 will be enrolled . patients will undergo routine blood investigations , ultrasound for sigmoid/descending colon thickness and colonoscopy will be done for histological assessment of each segment . all these parameters will be assessed will be compared to the clinical remission in patients of ulcerative colitis . we will study the radiological , biochemical , clinical and histological predictors of endoscopic healing in patients of ulcerative colitis on clinical remission |