Health Condition 1: D578- Other sickle-cell disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of SCD Patients experiencing recurrent pain crises Willingness to comply with the study protocol and followup schedule Written informed consent obtained
Exclusion criteria
Exclusion criteria: Patients with severe SCD complications requiring immediate intensive care History of blood transfusion in the last 3 months Pregnant or lactating women Patients on other alternative medical therapies for SCD Known hypersensitivity to study medication components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in frequency and severity of pain crises over 6 months (Based on Visual analogue score (VAS), Brief Pain Inventory (BPI), days with home analgesic use) Timepoint: Reduction in frequency and severity of pain crises over 6 months (Based on Visual analogue score (VAS), Brief Pain Inventory (BPI), days with home analgesic use) (Time baseline, 30th dy, 60th day, 90 th day, 120th day, 150th day, 180th day) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hemoglobin levels, reticulocyte count, and other hematological markers Reduction in hospitalizations and need for blood transfusions Patient-reported quality of life improvements Change in associated symptoms (fatigue, jaundice, infections, etc.) Safety parameters including liver and renal function testsTimepoint: Change in hemoglobin levels, reticulocyte count, and other hematological markers Reduction in hospitalizations and need for blood transfusions Patient-reported quality of life improvements Change in associated symptoms (fatigue, jaundice, infections, etc.) Safety parameters including liver and renal function tests (0,30,90,180th day) | — |
Countries
India
Contacts
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack