CTRI/2018/08/015526尚未招募Unknown
A Multi-centric, Double blind, Prospective, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract (CARIMAX), as empirical therapy for prevent Thrombocytopenia associated with Dengue Fever
Katra Phytochem Pvt ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 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 levels to the end of therapy
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 EastAsian countries on the effectiveness of carica papayaleaf extract onincreasing the platelet counts in patients with thrombocytopenia associatedwith Dengue.This trial is designed as Multi-centric, double blind, placebo controlled,Randomized, Prospective study in patients aged 18 years and above andhaving 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who were confirmed to have DF or DHF grade I and II, 2.Subjects must sign with date an Informed Consent (ICF) prior to any evaluation and participation in the trial, 3.Male and female patients above 18 years and below 60 years old, 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),.
排除标准
- •Pregnant or lactating women, 2.Patients with Dengue hemorrhagic fever grade III and IV, 3.Patients with platelet count less than 20000/microlitre 4.Patients with thrombocytopenia presenting with active bleeding 5.Patients who have received blood or blood products transfusion during the current illness or during past one week, 6.Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia or bleeding diathesis 7.Patients who developed Hepatitis with a serum ALT level 3 times higher than the upper limit of the normal range (>165 U/L).
- •8.Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females) 9.Participation in another trial with another investigational drug within 1 month prior to informed consent.
- •10.The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study 11.Hypersensitivity to any of the components of the investigational formulation.
结局指标
主要结局
Increase in the platelet counts from the baseline 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(Change in WBC levels from the baseline levels till the end of therapy)
研究者
研究点 (1)
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