| CTRI Number |
CTRI/2024/06/068355 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Impact of antioxidant cocktail in transfusion dependent beta thalassemia |
|
Scientific Title of Study
|
Impact of antioxidant cocktail in treatment of transfusion dependent beta thalassemia |
| 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 Arti Purohit |
| Designation |
PG resident |
| Affiliation |
Shyam shah medical college |
| Address |
pediatric department GMH shyam shah medical college rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
9587119282 |
| Fax |
|
| Email |
drartipurohit744@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra singh |
| Designation |
Assistant profesor |
| Affiliation |
Shyam shah medical college |
| Address |
pediatric department gandhi memorial hospital shyam shah medical college rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7024968393 |
| Fax |
|
| Email |
drsuansh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra singh |
| Designation |
Assistant profesor |
| Affiliation |
Shyam shah medical college |
| Address |
pediatric department gandhi memorial hospital shyam shah medical college rewa
Rewa
MADHYA PRADESH
486001
India |
| Phone |
7024968393 |
| Fax |
|
| Email |
drsuansh@gmail.com |
|
|
Source of Monetary or Material Support
|
| shyam shah medical college
Rewa pincode (486001) (M.P) India |
|
|
Primary Sponsor
|
| Name |
Arti Purohit |
| Address |
Shyam shah medical college Rewa pincode (486001) (M.P) 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 |
| Dr Arti Purohit |
Gandhi Memorial Hospital |
pediatric department gandhi memorial hospital Shyam shah medical
college
Rewa
MADHYA PRADESH
Rewa
MADHYA PRADESH |
9587119282
drartipurohit744@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.S Medical College Rewa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D561||Beta thalassemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
beta thalassemia major |
antioxidant cocktail - oral route
Vit-E 400 IU/day,
200mg/day N Acetyl cysteine
50mg/kg/day Deferiprone
this will be given for 1 year |
| Comparator Agent |
beta thalassemia major |
not taking antioxidant cocktail |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 1-18 years
2. Hb concentration 4–9g/L
|
|
| ExclusionCriteria |
| Details |
Major congenital anamolies child will be excluded |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hb level
2. Blood transfusion numbers in a year
3. changes in liver enzymes |
baseline
after 3 months
then at 6th month
then at 9th month
then finally after 1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in coagulation profile |
baseline
at 6months
at 1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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 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
|
The subjects will be divided into 2 equal
groups . one group will be treated with a antioxidant cocktail for 12 months. That group will receive
Vit-E 400 IU/day, 200mg/day NAC, and 50mg/kg/day DFP. And other group will not receive
antioxidant cocktail .this group will be for comparison with 1st group. after starting this antioxidant
cocktail we will see hemoglobin of pt at regular interval of 3 months and follow up this for 1 year and
then compare this with those thalassemia pt in which antioxidant was not given purpose of this trial is to reduce blood transfusion frequency in transfusion dependent
thalassemic pts |