CTRI/2018/10/016216Not yet recruitingPhase 3
A single center open-label non-comparative single-dose pilot clinical study evaluating efficacy and safety of standard intramuscular preparation of Paracetamol available in the market for the management of fever
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Similar Trials
Completed
Phase 1
A clinical trial to assess the bioavailability and safety of nano-atropine sulfate by dry powder inhalation in healthy human volunteers for nerve gas poisoningCTRI/2010/091/001350Defence R&D Organisation6
Completed
Phase 3
CLINICAL STUDY EVALUATING EFFICACY AND SAFETY OFINTRAMUSCULAR INJECTION OF PARACETAMOL 500MG/ 2ML IN THE MANAGEMENT OF FEVERCTRI/2021/01/030201Troikaa Pharmaceuticals Ltd
Completed
Phase 1
A clinical trial to assess the bioavailability and safety of atropine sulfate injected by sublingual submucosal injection in healthy human volunteers for nerve gas poisoningCTRI/2010/091/001352Defence R&D Organisation6
Completed
Phase 1
A clinical trial to assess the bioavailability and safety of atropine sulfate by intranasal drops in healthy human volunteers for nerve gas poisoningCTRI/2010/091/001347Defence R&D Organisation6
Completed
Phase 1
A clinical trial to assess the efficacy and safety of atropine sulfate by inhalation in healthy human volunteers for nerve gas poisoningCTRI/2010/091/001351Defence R&D Organisation6