CTRI/2023/04/052141招募中3 期
An Ayurvedic intervention as an add on for prevention of acute pain crises in Sickle Cell Anaemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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