CTRI/2018/07/014988已完成Unknown
A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, (ZYBORICA TABLET ) as empirical therapy for thrombocytopenia associated with dengue fever
Mi Lab LifeSciencesP Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月23日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in the platelet counts from the baseline
研究概览
简要总结
Carica papayaleaf extract has attracted attentions because of the promising results shown from the various studies conducted in South East Asian countries on the effectiveness of carica papayaleaf extract on increasing the platelet counts in patients with thrombocytopenia associated with Dengue. This trial is designed as Multi-centric, double blind, placebo controlled, Randomized, Prospective study in patients aged 18 years and above and having thrombocytopenia associated with dengue fever
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients above 18 years and below 60 years old, 2.Patients who are confirmed to have DF or DHF grade I and II by NS1 antigen test, 3.Patients having thrombocytopenia with at platelet count between 30,000 /micro litre to 150,000/micro litre, 4.Patients with a baseline alanine transaminase (ALT) level of not more than 3 times of the upper limit of the normal range (not more than 165 U/L), 5.Patient who is willing to give informed consent to participate in study.
排除标准
- •1.Patients with Dengue hemorrhagic fever grade III and IV, 2.Patients with platelet count less than 30,000/micro litre, 3.Pregnant or lactating women, 4.Patients who have received blood or blood products transfusion during the current illness, 5.Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia, 6.Patients who have a serum ALT level 3 times higher than the upper limit of the normal range (>165 U/L), 7.Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females) 8.Participation in another trial with an investigational drug within 1 month prior to this trial.
- •Hypersensitivity to any of the components of the formulation, 10.The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
结局指标
主要结局
Increase in the platelet counts from the baseline
时间窗: Day 1,Day 2,Day 3,Day 4 and Day 5
levels to the end of therapy
时间窗: Day 1,Day 2,Day 3,Day 4 and Day 5
次要结局
- Change in the RBC levels from the baseline(levels till the end of therapy)
研究者
研究点 (1)
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