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To compare effect of drugs L-carnitine and N-Acetyl-Cysteine in blood transfusion dependent thalassemia patients

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 - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068935
Enrollment
100
Registered
2024-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

Intervention1: L-Carnitine: 1000mg once a day for 6 months Intervention2: N-acetyl-cysteine: 600 mg once daily for 6 months Control Intervention1: placebo: once daily for 6 months

Sponsors

Dr Pragna Roy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with thalassemia on blood transfusion 2)Patients or legally authorized representative willing to give informed consent and assent for the trial.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Difference between N-Acetyl-Cysteine Vs L-Carnitine in the level of change in oxidative stress markers like MDA, GSH, SODTimepoint: Two years

Secondary

MeasureTime frame
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 Timepoint: Two years

Countries

India

Contacts

Public ContactDr Waseem Rizvi

Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh

waseemnakhat@gmail.com9897686003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026