Health Condition 1: D561- Beta thalassemia
Conditions
Interventions
Intervention1: Hydroxyurea: Upto 15mg per kg per day orally for 6 months
Intervention2: Thalidomide: Upto 3mg per kg per day orally along with Aspirin 5mg per kg per day orally for 06 months
Intervent
Sponsors
DGAFMS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of transfusion-dependent thalassemia 2. ECOG: 0 to 2 scores 3. Blood transfusion to maintain the Hb or level of Hb 4. Sign an informed consent agreeing to the clinical trial participation
Exclusion criteria
Exclusion criteria: 1. Patients with comorbidities like severe heart or lung diseases, liver dysfunction, renal dysfunction, malignancy, cerebrovascular disease, or other serious primary diseases 2. Patients allergic to the drug ingredients 3. Patients with any mental health problem 4. Patients had participated in other drug clinical trials in the past 1 month 5. Patients had a history of venous or arterial thrombosis 6. Childbearing age unwilling to use contraceptive measures 7. In certain circumstances the researchers determined it was not suitable for the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood transfusion pre and post intervention in ml/kg/monthTimepoint: at 06 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum Ferritin pre and post intervention 2. Nadir Hemoglobin pre and post interventionTimepoint: at 06 months | — |
Countries
India
Contacts
Public ContactNirmal Shrestha
Armed Forces Medical College
Outcome results
None listed