| CTRI Number |
CTRI/2024/12/078566 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Anti-oxidative and anti-inflammatory biomarkers level on treatment with different drugs in IBD patients |
|
Scientific Title of Study
|
Comparative evaluation of anti-oxidative and anti-inflammatory biomarkers level on treatment with Prednisolone, Mesalazine and Azathioprine in different groups of IBD patients |
| 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 Savita Devi |
| Designation |
Research Scientist-I |
| Affiliation |
Kalpana Chawla Govt. Medical College Karnal |
| Address |
MULTIDISCIPLINARY RESEARCH UNIT
KALPANA CHAWLA GOVT. MEDICAL COLLEGE KARNAL
Karnal
HARYANA
132001
India |
| Phone |
|
| Fax |
|
| Email |
savitajohn4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Devi |
| Designation |
Research Scientist-I |
| Affiliation |
KALPANA CHAWLA GOVT. MEDICAL COLLEGE KARNAL |
| Address |
MULTIDISCIPLINARY RESEARCH UNIT
KALPANA CHAWLA GOVT. MEDICAL COLLEGE KARNAL
Karnal
HARYANA
132001
India |
| Phone |
9518189146 |
| Fax |
|
| Email |
savitajohn4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Devi |
| Designation |
Research Scientist-I |
| Affiliation |
KALPANA CHAWLA GOVT. MEDICAL COLLEGE KARNAL |
| Address |
MULTIDISCIPLINARY RESEARCH UNIT
KALPANA CHAWLA GOVT. MEDICAL COLLEGE KARNAL
Karnal
HARYANA
132001
India |
| Phone |
9518189146 |
| Fax |
|
| Email |
savitajohn4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, New Delhi, India, Pin Code: 110001 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF HEALTH RESEARCH |
| Address |
NEW DELHI, India, Pin Code: 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Savita Devi |
MRU, Kalpana Chawla Govt. Medical College, Karnal |
MRU, 4TH FLOOR, MEDICAL COLLEGE BLOCK, KCGMC, KARNAL
Karnal
HARYANA |
9518189146
savitajohn4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KCGMC, Karnal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Azathioprine |
evaluation of anti-oxidative and anti-inflammatory biomarkers level on treatment with Azathioprine tablet oral treatment of one month duration daily OD or BD (depending on disease severity) of 50mg or depending on disease severity |
| Intervention |
Mesalazine |
evaluation of anti-oxidative and anti-inflammatory biomarkers level on treatment with Mesalazine tablet oral treatment of one month duration daily BD or depending on disease severity of 500mg to 1000mg or depending on disease severity |
| Intervention |
Prednisolone |
Evaluation of anti-oxidative and anti-inflammatory biomarkers level on Prednisolone tablet oral treatment of one month duration daily OD or BD (depending on disease severity) of 20mg or depending on disease severity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of 18-60 yrs age group
2. Patients willing to provide written informed consent
3. Patients diagnosed with IBD
|
|
| ExclusionCriteria |
| Details |
1. Patients with smoking, or alcohol addiction during the last 3 months
2. Patients who are not willing to provide written informed consent
3. Pregnant and lactating women
4. Patients with history of allergy to the study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This is the first study which will emphasis over the biomarkers status at antioxidative and anti-inflammatory level which is required in the present time to develop a long term effective therapy for IBD patients |
at baseline and after one month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a long term effective therapy along with no or little side effects for the better lifestyle of IBD patients |
1 At baseline
2 after one month of treatment |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/01/2025 |
| 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 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
Modification(s)
|
This Randomized controlled trial has withdrawn due to non-availability of patients at the site (no patient is recruited) and withdrawal was approved by the funding agency and informed to the Institutional Ethics Committee, kindly withdraw the study from CTRI also |