| CTRI Number |
CTRI/2026/02/104006 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The role of prednisolone in preventing intestinal complications in patients of Abdominal TB |
|
Scientific Title of Study
|
Double blind, parallel arm randomized controlled trial for preventing intestinal complications by concomitant prednisolone with standard anti-tuberculosis regimen in patients of abdominal tuberculosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitish Sharma |
| Designation |
Medicine resident |
| Affiliation |
Jawaharlal nehru medical college and hospital, AMU |
| Address |
Department of medicine, jawaharlal nehru medical college, aligarh Muslim university, aligarh, UP, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9262977086 |
| Fax |
|
| Email |
cmjr1905@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Husaini S. Haider Mehdi |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal nehru medical college and hospital, AMU |
| Address |
Department of medicine, jawaharlal nehru medical college, aligarh Muslim university, aligarh, UP, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8958786889 |
| Fax |
|
| Email |
hadyman2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitish Sharma |
| Designation |
Medicine resident |
| Affiliation |
Jawaharlal nehru medical college and hospital, AMU |
| Address |
Department of medicine, jawaharlal nehru medical college, aligarh Muslim university, aligarh, UP, India
UTTAR PRADESH
202002
India |
| Phone |
9262977086 |
| Fax |
|
| Email |
cmjr1905@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of medicine, J.N.M.C.H, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
nitish sharma |
| Address |
Department of medicine, jawaharlal nehru medical college, aligarh Muslim university, aligarh, UP, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Nitish Sharma |
JAWAHARLAL NEHRU MEDICAL COLLEGE AMU ALIGARH |
Department of medicine, ward 11; 12, and OPD, jawaharlal nehru medical college and hospital Aligarh Muslim University
Department of medicine critical care ward Jawaharlal Nehru medical college and hospital Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India
Aligarh
UTTAR PRADESH |
09262977086
snitish81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Jawaharlal Nehru medical college and hospital Aligarh Muslim University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A183||Tuberculosis of intestines, peritoneum and mesenteric glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ATT plus placebo |
Standard anti-tubercular drug regimen (per the National TB Elimination Programme guidelines for abdominal TB) for 6-9 months plus Placebo for 3 months
|
| Intervention |
ATT plus Steroid |
Standard anti-tubercular drug regimen (per the National TB Elimination Programme guidelines for abdominal TB) for 6-9 months plus oral Prednisolone for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender and Age more than 14 years
Newly diagnosed and treatment naïve patients of abdominal tuberculosis
Willing and able to provide written informed consent
Able to comply with the study protocol and follow-up schedule
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients in each arm who develop at least one of the following within 12 months of initiating treatment: Intestinal stricture, Intestinal obstruction, Need for abdominal surgery.
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Self
- For how long will this data be available start date provided 03-10-2025 and end date provided 03-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
India contributes 28% of TB cases globally. According to The Global TB Report 2020, Extrapulmonary tuberculosis (EPTB) constituted 16% of the 7.5 million reported TB cases globally and 19% in South-East Asia(1). Abdominal tuberculosis (TB) constitutes 11-13% of EPTB in India. It is a double blind, randomised, parallel arm controlled trial for preventing intestinal complications by concomitant prednisolone with standard anti-tubercular regimen in patients of abdominal tuberculosis. All randomised patients will be either placed on ATT plus steroid or ATT plus placebo.
|