Health Condition 1: D648- Other specified anemias
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed sickle cell disease patients using HPLC & who are not on hydroxyurea for past 1month
Exclusion criteria
Exclusion criteria: 1 Alcoholic with 2 or more positive CAGE questionnaire 2 Pregnant females 3 Any significant complications (ACS, Sequestration crisis, CKD etc.) 4 Smokers with more than 20 pack years 5 Presence of infectious diseases (Pneumonia, Meningitis, bacterial sepsis etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Evaluation in change of inflammatory biomarkers with treatment using hydroxyurea at baseline and 6months. 2 Evaluation in change of oxidative stress markers with treatment using hydroxyurea at baseline and 6months. Timepoint: 1 Evaluation in change of inflammatory biomarkers with treatment using hydroxyurea at baseline and 6months. 2 Evaluation in change of oxidative stress markers with treatment using hydroxyurea at baseline and 6months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Association of clinical parameters (Number of VOC, Number of blood transfusions, Number of hospital admissions) with biomarkers (inflammatory & biomarkers) at 6 months of hydroxyurea therapy 2 Evaluation in change in haematological parameters (HbF, HbS, CBC for leucocyte count) with treatment using hydroxyurea at baseline & at 6months 3 Evaluation of compliance to hydroxyurea treatment in the 6 months duration 4 Evaluation of ADR with hydroxyurea therapy in the 6 months duration 5 Assessment of change in quality of life using SF-36 questionnaire at baseline & at 6 months Timepoint: 6months | — |
Countries
India
Contacts
AIIMS Nagpur