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Effects of Hydroxyurea and Metformin in Transfusion Dependent Beta-Thalassemia
Sponsor: Bahria University
Summary
This clinical trial aims to evaluate and compare the effects and safety of hydroxyurea and metformin in transfusion-dependent beta-thalassemia major and correlate responders/non-responders with the single nucleotide polymorphism mutations (SNPs) by DNA analysis. The main question to answer is: * Is there a significant difference in the effects and safety of hydroxyurea and metformin in transfusion-dependent beta-thalassemia major? Participants will be divided into two treatment groups. Participants of group A will receive Tab. Metformin 500mg/dose twice daily orally for one year. Participants of group B will receive Tab. Hydroxyurea 10-20mg/kg once daily orally for one year. At the end of the study, Investigators will compare the effects and safety of hydroxyurea and metformin in transfusion-dependent beta-thalassemia major and correlate responders/non-responders with the single nucleotide polymorphism mutations (SNPs) by DNA analysis.
Key Details
Gender
All
Age Range
10 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-09-16
Completion Date
2026-04-30
Last Updated
2024-12-17
Healthy Volunteers
No
Conditions
Interventions
Tablet Metformin (Group A)
Tablet Metformin 500 mg/dose orally twice a day with meal for 1 year
Tablet Hydroxyurea (Group B)
Tablet Hydroxyurea 10-20mg/kg once daily orally with breakfast for 1 year
Locations (1)
Bahria University Health Sciences Campus
Karachi, Sindh, Pakistan