Health Condition 1: D648- Other specified anemias
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: i)Must have sickle cell anemia confirmed by hemoglobin electrophorosis analysis with HbSS ii) Participants must have the laboratory indices as defined below: ?Hemoglobin > 6 g/dL ?Platelets > 100,000/mcL ?Serum creatinine = 1.5 mg/dL or upper normal limit ?INR =2.0, PTT = 48 seconds iii)Express willingness to adhere to the trial procedures and follow-up schedule iv)Willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. 5 or more hospitalizations for pain in the last 12 months 2. Receiving regularly scheduled transfusions more than once in every 3 months 3. History of a bleeding diathesis 4. History of clinically overt stroke within 2 years 5. Receiving chronic anti-coagulation or anti-platelet therapy 6. Have previously undergone a hematopoietic stem cell transplant or solid organ transplant 7. Red cell transfusion within 60 days 8. Patients who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction and Stroke. 9. Symptomatic patients with clinical evidence of congestive cardiac failure. 10. Chronic liver disease or two times upper limit of normal level of ALT/AST 11. Patients having BP = 160/100 mmhg. 12. Clinically significant infection episodes. 13. Unable to take oral medications or having malabsorption syndrome. 14. Active substance abuse. 15. Patients with concurrent Renal Dysfunction (defined as S. creatinine > 1.5 mg/dl. 16. Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 17. Known cases of Hepatitis. 18. Patients with HBA1C - = 8. 19. Known cases of HIV and AIDS. 20. Known cases of malignancy. 21. Patients of Hyperthyroidism. 22. Patient taking participation in any other clinical trial. 23. Women who are planning for conception / pregnant or lactating. 24. Any other condition which the P.I. thinks may jeopardize the study. 25. Heterozygous sickle cell trait (AS pattern). 26. Evidence of severe sickle-cell crisis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in incidence or frequency of sickle cell-related pain crises.Timepoint: Baseline, 30th Day, 60th Day, 105th Day, 150th Day, 195th Day, 190th Day, 240th Day & follow-up after completion of 240th day between 3 to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute change from baseline in hemoglobin 2. Absolute change from baseline in lactate dehydrogenase 3. Decrease in frequency in episodes of Bleeding during the treatment period 4. Decrease in the frequency in number of RBC transfusions related to sickle cell-anaemia 5. Decrease in frequency of hospital admissions due to pain, during the treatment period 6. Improvement in hematological parameters (CBC, HbS, HbF, HbA). 7. Change in pain intensity measured by VAS 8. Duration of hospital stay 9. Incidence of Adverse events (with frequency & severity) 10. Need of analgesics/opioids use for pain. 11. Mean change in Indirect Bilirubin, Potassium & free haptoglobin & change in the levels of inflammatory marker CRP. 12. Assessing the Fatigueness (Modified Fatigue Impact Scale) 13. Assessing the quality of life through scale SF-12 14. Analysis of Ayurvedic Parameters [Prakruti]Timepoint: Baseline, 30th Day, 60th Day, 105th Day, 150th Day, 195th Day, 190th Day, 240th Day & follow-up after completion of 240th day between 3 to 6 months | — |
Countries
India
Contacts
Public ContactDr U R Sekhar Namburi
Regional Ayurveda Research Institute
Outcome results
None listed