| CTRI Number |
CTRI/2025/12/098993 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of N-acetylcysteine in reducing cardiac iron overload in children with transfusion-dependent thalassemia.”
|
|
Scientific Title of Study
|
Effect of N-acetylcysteine on cardiac iron status in transfusion dependent thalassemia children - A Randomized control trial. |
| 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 Alka Yadav |
| Designation |
Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYAN |
| Address |
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
8607407313 |
| Fax |
|
| Email |
alkadv9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keshika |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYANA |
| Address |
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
8168328951 |
| Fax |
|
| Email |
bansalkeshika389@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keshika |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYANA |
| Address |
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
8168328951 |
| Fax |
|
| Email |
bansalkeshika389@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS),Rohtak ,Haryana-124001 |
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS),Rohtak ,Haryana-124001 |
| 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 Keshika |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS),Rohtak |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS),Rohtak ,Haryana-124001
Rohtak
HARYANA |
8168328951
bansalkeshika389@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
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 |
N -acetylcysteine |
“Intervention group will receive oral N-acetylcysteine 10 mg/kg once daily for 6 months, administered with food along with standard iron chelation therapy.” |
| Comparator Agent |
No intervention In control arm |
Participants in the control arm will receive only standard iron chelation therapy. No N-acetylcysteine or additional intervention will be given. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 10 to 18 years diagnosed with beta thalassemia( on regular transfusion for 1 year) |
|
| ExclusionCriteria |
| Details |
Children with either of the following conditions will be excluded:
1.Children with documented renal and liver dysfunction/endocrine/ cardiac dysfunction
2.Receiving any supplementation (other than folic acid) within the past one month
3.Child on any cardioprotective drugs
4.Known hypersensitivity to N-acetylcysteine
5.Refusal of consent by parent/guardian
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cardiac iron status |
At enrollment and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in MIC and echo findings in relation to serum ferritin levels after 6 months of NAC supplementation.
Frequency of transfusions requirements (e.g. Average pre-transfusion haemoglobin, average transfusion interval, average transfusion volume) during study period.
Any adverse effects related to NAC (infections, hospitalization, worsening anaemia).
|
at 0, 3 , 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/12/2025 |
| 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 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
|
A randomized controlled trial study design will be used. Subjects will be defined as children aged 10 years-18 years of either gender with transfusion dependent beta-thalassemia diagnosis based on clinical phenotype and HPLC. A feasibility sample of 60 patients with 30 patients in each group will be enrolled. The patients will be randomized in two groups using computer generated random number sequence. Allocation concealment will be done using serially numbered opaque sealed envelopes that will contain a paper slip with name of allocation group. The duration of study would be 1 year. Demographic and clinical data will be recorded. Anthropometry and Clinical examination will be performed. Baseline hematologic investigations will be sent along with ECG, Echocardiography (In the department of cardiology at Lala shyam lal building) and cardiac MRI (to be done in PGIMS trauma centre as poor free on special request). No additional charges will be born by patient for any of these investigations. Children in study group will receive tablet N -acetylcysteine at a dose of 10 mg/kg orally, once daily for six months, available in PGIMS central store as 600 mg tablet. This tablet is to be taken with food along with other medications.control group will not recieve n acetylcysteine will only recieve standard chelation therapy. |