A Randomized, Open label, parallel group, Comparative clinical study to evaluatethe efficacy and safety of HYDRODENG SACHET with Cariprill in Dengue fever. - NI

Tirupati Medicare Limited, India.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1. Proper written informed consent obtained from the patient before any
•procedure performed.
•2. Males and females between the age of 18-75 years with an oral temperature of
•more than 38.0°C (100.4°F). with or without associated rash, body pain and joint
•pain, severe headache especially behind the eyes, nausea and vomiting.
•3. Patients having confirmed Dengue Viral fever (Positive NS1 antigen card
•test) with thrombocytopenia, with a platelet count between 50,000 /micro
•litre to150,000/micro litre.
•4. Subjects with stable vitals like pulse and blood pressure
•5. Patient should have not participated in any other clinical trial during the past 3

•1. Patients with Dengue hemorrhagic fever grade III and IV
•2. Patients with platelet count less than 50,000/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(greater than 165 U/L),
•7. Impaired renal function with serum creatinine greater than 1.5 mg/dl ( males) and greater than 1.4 mg/dl(females),
•8. Hypersensitivity to any of the components of the formulation,
•9. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

发起方

Tirupati Medicare Limited, India.