Health Condition 1: null- Adult patients suffering from pyrexia
Conditions
Interventions
Intervention1: Paracetamol 650 mg: 650 mg
TiD orally, every 8 hours for one day
Control Intervention1: Paracetamol 500mg: 500 mg
TiD orally, every 8 hours for one day
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pyrexia (axillary temperature >= 37.5 ° C) 2.H/o of pyrexia during the previous 24 hours 3.Patients whose fever is not controlled even on antibiotics 4.Fever of any origin 5.Provide written informed consent prior to participation in the study 6.Have the ability to read and understand the study procedures 7.Have the ability to communicate meaningfully with the study investigator and staff 8.With a fever episode justifying a paracetamol treatment for a minimum duration of 24 hours
Exclusion criteria
Exclusion criteria: 1.H/o medication with antipyretics, steroids or NSAIDs in the past 2 days 2.Patients who are unable to swallow/drink 3.H/o hypersensitivity to the study medication 4.Recent history of convulsions (one or more in the previous 24 hours); impaired consciousness Based on history and previous reports which indicate the presence of immunological, endocrinal diseases, serious renal, hepatic, cardiac, neurological, psychiatric or metabolic disease. 5.Critical ill patients 6.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 7.Patients with peptic ulceration or gastric bleeding, hemorrhagic diathesis of the upper or lower digestive tract 8.Pregnant or lactating women 9.Cold medications containing antipyretics 10.Any patient who has participated in another clinical trial within previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in body temperature from baseline (at 0 min) to 24 hours after administration of paracetamol 650 mg tablet when compared to paracetamol 500 mg tabletTimepoint: 24 hours after administration of paracetamol 650 mg tablet when compared to paracetamol 500 mg tablet | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and efficacy of paracetamol 650mg tablets as compared to paracetamol 500mg tabletsTimepoint: 24 hours after administration of paracetamol 650 mg tablet when compared to paracetamol 500 mg tablet | — |
Countries
India
Contacts
Public ContactDr RV Lokeshkumar
Micro Labs Limited, Bangalore
Outcome results
None listed