To evaluate the safety of Paracetamol 650 mg tablet with Paracetamol 500 mg tablet in adult patients with fever

Phase 4

• Conditions: Health Condition 1: null- â?¢Fever of any origin in adults who are hospitalized will be enrolled in this study. Patients with fever visiting the hospital will be screened for the eligibility into the study.

• Registration Number: CTRI/2012/11/003161
• Lead Sponsor: MICRO LABS LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

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 ° 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.

Exclusion Criteria

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified