Health Condition 1: D57- Sickle-cell disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed patient of Sickle Cell Disease with reported episodes of acute vaso-occlusive crisis anytime in last 3 months Individuals with vaso occlusive crisis on day of enrollment will be enrolled after the episode of acute crisis is over.
Exclusion criteria
Exclusion criteria: Individuals having any severe complication of sickle cell disease like acute chest syndrome (ACS), aseptic necrosis of bone, etc. Individuals with any another hemolytic anemia such thalassemia, G6PD, hereditary spherocytosis, hemolytic uremic syndrome, etc. Individuals who have had bone marrow transplantation Individuals with self reported addictions to alcohol, severe end stage comorbidities like stroke, end stage kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in frequency, duration and intensity (FDI) of acute Vaso-occlusive pain crisis episodes Frequency will be measured as number of episodes each week Duration will be measured as number of days with pain severe enough to affect daily activities Intensity will be measured on VAS scale as the most severe pain occurring anytime during the acute episode Number of blood transfusions required during the follow up period Timepoint: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hematological and biochemical parameters at 6 months and at 12 months as compared to baseline o Haemoglobin o TIBC (Total Iron Binding Capacity) o Red cell count o PCV (Packed Cell Volume) o MCV (Mean Corpuscular Volume) o MCH (Mean Corpuscular Haemoglobin) o MCHC (Mean Corpuscular Haemoglobin Concentration) o RDW (Red Cell Distribution Width) o Reticulocyte count o Serum ferritin o Serum iron o Vitamin B12 o Folic acid o Liver Function Test o Renal Function Test o Peripheral smear o Transferrin saturation percentage Number of days of missed work and loss of daily wages Assessment of quality of life based on Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at baseline, 6 month and 12 months Timepoint: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months. | — |
Countries
India
Contacts
Central Council for Research in Homoeopathy