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
- 入组人数
- 1,510
- 试验地点
- 2
- 主要终点
- Reduction in incidence or frequency of sickle cell-related pain crises.
研究概览
简要总结
Sickle cell anemia is one of a group of disorders knownas sickle cell disease. It is a hereditary defectconfined to RBC where basic defect in the structure of Hemoglobin molecule.These cells acquire sickle like shape of RBCs and in hypoxic condition, causes early destructionleads to Anemia. The main clinical features are joint pain, jaundice andAnaemia. SCD is not curable by medicine or surgery. Presently Stem cell Therapyand Gene therapy are available which are very expensive. The drugs likeHydroxyurea are useful to reduce severity of symptoms but not affordable to people. The only possible symptomatictreatment is folic Acid, NSAID’s Soda-bicarbonate. At this scenario it wasdecided to study this disorder in Ayurvedic perspective and to develop aprotocol of Ayurvedic management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
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.
- •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.
结局指标
主要结局
Reduction in incidence or frequency of sickle cell-related pain crises.
时间窗: Baseline, 30th Day, 60th Day, 105th Day, 150th Day, 195th Day, 190th Day, 240th Day
次要结局
- 1.Absolute change from baseline in hemoglobin(2.Absolute change from baseline in lactate dehydrogenase)