CTRI/2019/04/018435尚未招募Phase 3 4
Profile of Dengue Fever and effect of carica papaya leaf extract capsule on platelet counts and clinical bleeding
Dinesh babu1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年10月4日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- 1. To describe the clinical profile of dengue fever in adult patients admitted in PIMS
研究概览
简要总结
As many physicians in india use carica papaya leaf extract capsule for improvement in platelet counts in dengue fever , but there are very few studies proving their benefit. Hence this study was done in my institution to study the effect of the drug.
Commercially available carica papaya leaf capsule is given as 1100 mg thrice daily for 5 days and hypothesised that it will increase or prevent fall in platelet counts in dengue fever and reduce hemorrhagic manifestations
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged more than 18 yrsadmitted with fever and dengue Ns1Ag (OR) IgM positive.
排除标准
- •Patients with chronic liver disease
- •Patients with dengue co-infectionlike malaria , typhoid , scrub typhus.
- •Patient with platelet disorders (eg:Immune thrombocytopenic purpura)
- •Pregnant women with dengue fever.
结局指标
主要结局
1. To describe the clinical profile of dengue fever in adult patients admitted in PIMS
时间窗: 8 months
2. To determine the effect of carica papaya leaf extract capsuleon platelet counts in adult patients of dengue fever admitted in PIMS
时间窗: 8 months
次要结局
- Whether carica papaya leaf extract capsule reduce hemorrhagic manifestations(10 months)
研究者
研究点 (1)
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