A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue feverSafety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever

Micro Labs Ltd0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects must sign with date an Informed Consent (ICF) prior to any evaluation and participation in the trial,
•2.Male and female patients above 18 years and below 60 years old,
•3.Patients who were confirmed to have DF or DHF grade I and II,
•4.Patients with a platelet count of less than 100,000/Î¼L,
•5.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 165U/L),

•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 ( >165â??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.

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