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.
Conditions
Interventions
Intervention1: Paracetamol 650mg tablet: A 2 ml blood sample will be collected from all the subjects in heparinzed tube to evaluate Liver function test (LFT) at the beginning (i.e., before the first d
Sponsors
MICRO LABS LIMITED
Eligibility
Inclusion criteria
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
Exclusion criteria: Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Evaluation of liver function â?¢Percentage of patients with adverse events â?¢Percentage of patients with serious adverse events â?¢Percentage of patients withdrawn due to adverse eventsTimepoint: Total study duration is 16 weeks and treatment duration is 3 days (single period study) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in baseline body temperature at 24 hours from start of treatment, change in baseline temperature at the end of 2nd and 3rd day. â?¢Time of onset of treatment and time to return of temperature to normal i.e., â?¤ 37.5°C â?¢Overall Patients Global EvaluationsTimepoint: Total study duration is 16 weeks and treatment duration is 3 days (single period study) | — |
Countries
India
Contacts
Public ContactDr Gurudutt Nayak
Micro Labs Limited
Outcome results
None listed