CTRI/2018/07/014988已完成4 期
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 Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 165â??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 ( >165â??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.
- •9. 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.
研究者
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