Health Condition 1: D561- Beta thalassemia
Conditions
Interventions
Intervention1: Ceonathus Americanus 3X + Standard blood transfusion and Iron chelation therapy: 0.25 ml Twice a day for 120 days
Intervention2: Pulsatilla 200 + Standard blood transfusion and iron che
Sponsors
Jayadev Memorial Rashtrotthana Hospital, Bengaluru
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of either sex in the age group between 18-35 years. Subjects diagnosed with transfusion dependent thalassemia major or intermedia. Subjects with clinical splenomegaly confirmed via ultrasonography grade 1- 3 (Hacketl s grading). Subjects on stable doses of ongoing chelation therapy for iron overload management.
Exclusion criteria
Exclusion criteria: Subjects who have undergone splenectomy. Subjects who have grade 4 - 5 (Hacketl s grading) splenomegaly. Subjects who have splenomegaly other than thalassemia conditions like,liver cirrhosis with portal hypertension, infectious diseases like mononucleosis or malaria, hematological malignancies like leukemia or lymphoma, myeloproliferative disorders, sickle cell anemia, autoimmune diseases, infiltrative disorders like Gaucher disease, and certain genetic storage diseases. Subjects presenting with confirmed diagnosis of comorbid conditions such as Diabetes, Hypertension, Cardiomyopathy, Immune deficiency, hepatic dysfunction (defined as 3 times the upper limit of AST/ALT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in spleen size measured by ultrasound and palpationTimepoint: Baseline to 120th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Potential changes in Ferritin and CBCTimepoint: at baseline and after 40, 80 and 120 days of treatment;Changes in requirement of blood transfusionsTimepoint: Baseline to 120th day;Any changes in the safety parameters (LFT & RFT)Timepoint: at baseline and after 120 days of treatment | — |
Countries
India
Contacts
Public ContactKavya Nagarajan
Rashtrotthana Research Centre,
Outcome results
None listed