A randomized, double blind, multicentre comparative study to evaluate the safety of Paracetamol 650 mg tablet with Paracetamol 500 mg tablet in adult patients with fever.

MICRO LABS LIMITED0 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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•Age >= 18â??65 years and weight >= 41 kgs.
•History of fever during the previous 24 hours.
•Patients whose fever is not controlled even on antibiotics.
•Fever of any origin (axillary temperature >= 37.5 Â° C) including asthma and cancer patients.
•Provide written Informed Consent prior to participation in the Study.
•Have the ability to read and understand the study procedures.
•Have the ability to communicate meaningfully with the study Investigator and staff.
•With a fever episode justifying a Paracetamol treatment for a minimum duration of 24 hours.

•Age < 18 years and weight < 41 kg.
•H/o antipyretics in the past 2 days.
•Patients who unable to drink.
•H/o hypersensitivity to the study medication.
•Recent history of convulsions (one or more in the previous 24 hours); impaired consciousness.
•Based on the history and previous reports to rule out immunological; endocrinal diseases; serious renal, hepatic, cardiac, neurological, psychiatric or metabolic disease.
•Critically ill patients.
•Any other acute or chronic conditions in the opinion of the investigator, could interfere with the patients health and well being during the conduct of the study or the evaluation of the data.
•Patients with peptic ulceration or gastric bleeding, haemorrhagic diathesis of the upper or lower digestive tract.
•Pregnant or lactating women.
•Alanine transaminase (ALT), Aspartate transaminase (AST) greater than 3 times the upper normal level according to the lab of the participating hospital.
•Individuals with known drug dependency and alcohol abuse.
•If the patients treated with steroids or NSAIDs within 2 days.
•Cold medications containing antipyretics.
•Lack of informed consent.
•Any patient who has participated in another clinical trial within previous 4 weeks.

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