A Taste and Efficacy Comparison of Two Paracetamol Preparations for the Treatment of Fever in Children - Fever - TEC

Pulse Pharmaceuticals Pvt. Ltd.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

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•i.Male and female subjects from the age of =3 years to 12 years (both inclusive) are eligible to participate in the study.
•ii.Only participants requiring treatment on an outpatient basis will be recruited.
•iii.The body temperature should be at least 38.5°C/ 101.3°F, with an upper boundary of 40°C/ 104°F associated with various pathologies such as sore throat, influenza, respiratory tract infection, ear infection or immunization.
•iv.Parents of all patients will provide signed Informed Consent and patients in the age group of 7-12 will give their own consent along with that of their parents’.

•i.Hypersensitivity to any of the study drug constituents.
•ii.A history of any condition that interfered with the absorption, distribution, metabolism or excretion of the study drug.
•iii.Patients with hepatic failure.
•iv.Patients with previous history of febrile convulsions.
•v.Patients, who had received treatment with an antipyretic drug up to 6 hours before inclusion, or treatment with antibiotic therapy in the 12 hours before the start of the trial, are also excluded.

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