Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- comparison of Serum glutamic pyruvic transaminase
研究概览
简要总结
The goal of this study is to compare the effectiveness and safety of two hemoglobin F inducer. This is single centered interventional pilot study is to compare the efficacy and safety parameters in beta thalassemia patients. As this is a pilot study, the investigator took a small number of patients. The Sample size was calculated by the World health organization sample size calculator. After screening 39 patients and 24 patients were eligible for enrollment in this study.
The main objective was to evaluate safety of both drugs in genetic disorder like thalassemia. for safety evaluation, hematological parameters were evaluated that includes total bilirubin , indirect bilirubin, Serum Glutamate Pyruvate Transaminase, serum glutamic-oxaloacetic transaminase, urea, creatinine and lactate dehydrogenase were monitored . Moreover to evaluate the efficacy of drug, hematological parameters that includes hemoglobin, red blood cells , nucleated red blood cells , reticulocytes count, Red blood cells indices ( mean corpuscular hemoglobin, mean corpuscular volume and mean corpuscular hemoglobin concentration) , white blood cells and platelets were done. Another important parameters to evaluate the efficacy of hemoglobin F inducer is transfusion frequency.
Test were done at baseline and after completion of study means after 06 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Know case of beta thalassemia age between 10-30 years
排除标准
- •Patients on any other haemoglobin F inducer or erythropoietin.
- •Patients with co-morbidities like cardiopulmonary and neurological disease
- •Pregnant, lactating women.
- •Patient did not willing to take contraceptive measures.
- •Participants with history of thrombosis.
研究组 & 干预措施
hydroxyurea
Hydroxyurea is available in oral dosage form which is capsule. frequency: once a day duration: at every 24 hours dose: 15/mg/kg/day.
干预措施: Thalidomide 100mg (Drug)
Thalidomide
Thalidomide is available in oral dosage form which is capsule. frequency: once a day at night duration: at every 24 hours dose:50 mg / day (in patients >10-13 years) while the adult dose was 100 mg /day (age >13 Years)
干预措施: Hydroxyurea (Drug)
结局指标
主要结局
comparison of Serum glutamic pyruvic transaminase
时间窗: 06 months
Serum glutamic pyruvic transaminase
comparison of glutamic-oxaloacetic transaminase
时间窗: 06 months
glutamic-oxaloacetic transaminase
comparison of white blood cells
时间窗: 06 months
white blood cells
comparison of platelets
时间窗: 06 months
Platelets
comparison of urea
时间窗: 06 months
Urea
comparison of creatinine
时间窗: 06 months
Creatinine
comparison of Lactate dehydrogenase baseline and after the completion of study.
时间窗: 06 months
Lactate dehydrogenase
comparison of hemoglobin
时间窗: 06 months
Hemoglobin
comparison of red blood cells
时间窗: 06 months
Red blood cells
comparison of Mean Corpuscular Hemoglobin concentration
时间窗: 06 months
Mean Corpuscular Hemoglobin concentration
comparison of Mean corpuscular volume
时间窗: 06 months
Mean corpuscular volume
comparison of Mean Corpuscular Hemoglobin
时间窗: 06 months
Mean Corpuscular Hemoglobin
comparison of Indirect bilirubin
时间窗: 06 months
Indirect bilirubin
comparison of Total Bilirubin
时间窗: 06 months
Total Bilirubin
comparison of tranfusion frequency baseline and after the completion of study.
时间窗: 06 months
Transfusion interval
次要结局
未报告次要终点
