| CTRI Number |
CTRI/2024/06/068935 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare effect of drugs L-carnitine and N-Acetyl-Cysteine in blood transfusion dependent thalassemia patients |
|
Scientific Title of Study
|
Comparative study for efficacy of L-carnitine and N-acetyl cysteine on iron overload induced oxidative stress in patients with thalassemia: 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. Pragna Roy |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical college, Aligarh Muslim University, Medical college road, AMU campus, Civil lines, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8258843568 |
| Fax |
|
| Email |
pragnaroy1912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Waseem Rizvi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical college, Aligarh Muslim University, Medical college road, AMU campus, Civil lines, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9897686003 |
| Fax |
|
| Email |
waseemnakhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Waseem Rizvi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical college, Aligarh Muslim University, Medical college road, AMU campus, Civil lines, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9897686003 |
| Fax |
|
| Email |
waseemnakhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical college, Aligarh Muslim University, Medical college road, AMU campus, Civil lines, Aligarh, Uttar Pradesh, India, Pin -202001 |
|
|
Primary Sponsor
|
| Name |
Dr Pragna Roy |
| Address |
Department of Pharmacology, Jawaharlal Nehru Medical college, Aligarh Muslim University, Medical college road, AMU campus, Civil lines, Aligarh, Uttar Pradesh, India, pin - 202001
|
| 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 Pragna Roy |
Jawaharlal Nehru Medical college and Hospital |
Departments of Pharmacology and Paediatrics, Jawaharlal Nehru Medical college, Aligarh Muslim University, Medical college road, AMU campus, Civil lines, Aligarh, Uttar Pradesh, India, pin - 202001
Aligarh
UTTAR PRADESH |
08258843568
pragnaroy1912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.), Jawaharlal Nehru Medical College & Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh, U.P, India - 202002 |
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 |
L-Carnitine |
1000mg once a day for 6 months |
| Intervention |
N-acetyl-cysteine |
600 mg once daily for 6 months |
| Comparator Agent |
placebo |
once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with thalassemia on blood transfusion
2)Patients or legally authorized representative willing to give informed consent and assent for the trial.
|
|
| ExclusionCriteria |
| Details |
1) Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition of N-Acetyl-Cysteine and L-Carnitine
2) Patients with history of central nervous system diseases (like epilepsy, psychiatric disorder) or taking any medicine for such illness.
3) Patients with history of severe renal or hepatic disease (like hepatitis B or C)
4) Patients with history of bronchospastic diseases (like asthma)
5) Patients with history of hypothyroid disorder
6) Patients on warfarin or acenocoumarin therapy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference between N-Acetyl-Cysteine Vs L-Carnitine in the level of change in oxidative stress markers like MDA, GSH, SOD |
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Difference between N-Acetyl-Cysteine Vs L-Carnitine in liver enzymes, lipoproteins, cardiac biomarkers
-2) Number of ADRs in arms of N-Acetyl-Cysteine and L-Carnitine
|
Two years |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="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
|
Comparative study for efficacy of L-carnitine and N-acetyl cysteine on iron overload induced oxidative stress in patients with thalassemia: A Randomized Control Trial. Total of 100 patients of Transfusion Dependent Thalassemia on chelators will be randomized into three arms. In one arm (n=40), N-Acetyl- Cysteine 600 mg tablet will be given orally once a day for 6 months and in the second arm (n=40), L-Carnitine 1000 mg/day tablet orally will be given once in day for 6 months while in the third arm (n=20) placebo tablet will be given once a day for 6 months. Patients will be given standard of care of iron chelator, vitamin E and C, folate therapy. Primary outcome measurement is to calculate difference between NAC Vs LC in the level of change in oxidative stress markers like MDA, GSH, SOD. |