single-dose clinical study evaluating efficacy and safety of standard intramuscular preparation of Paracetamol available in the market for the management of fever
- Conditions
- Health Condition 1: R509- Fever, unspecified
- Registration Number
- CTRI/2018/10/016216
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Having fever oral temperature between 101 to 104 F both inclusive of
recent onset more than 3 days and expected to be hospitalized more than 24 hrs
2 Willing to comply with study requirements including periodic
measurements or examinations laboratory investigations and avoiding
any intramuscular administration during the entire study
duration of 7 days as documented by provision of written Informed
Consent prior to participation in the study
1 Fever suspected to be due to neurological infection or any cancer
2 Patient receiving any IM injection for the co morbid condition and where the IM injection are expected to continue
3 High grade fever more than 104 F or suspected septicemia
4 Hypotension inferred from systolic blood pressure more than 90 mmHg
5 Admission in intensive care unit or intensive cardiac care unit
6 Severe kidney creatinine more than 2 mg per dl or liver disease SGOT and SGPT more than 3 times ULN and based on discretion of the investigator
7 Patients with serum CPK levels more than 5 times the ULN for that gender
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method