CTRI/2021/01/030201已完成3 期
A SINGLE CENTER OPEN-LABEL NON-COMPARATIVE SINGLE-DOSEmedical study to evaluate the efficacy and safety of INTRAMUSCULAR INJECTION OF PARACETAMOL 500MG/ 2ML for the treatment OF FEVER. - NI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Both male and female in the age group of 18-65 years (both inclusive)
- •Having fever (oral temperature between 101â??104ºF, both inclusive) of
- •recent onset ( < 3 days) & expected to be hospitalized >= 24 hrs.
- •Willing to comply with study requirements including periodic
- •measurements/examinations, laboratory investigations and avoiding
- •any intramuscular (IM) administration during the entire study
- •duration of 7 days, as documented by provision of written Informed
- •Consent prior to participation in the study
排除标准
- •Fever suspected to be due to neurological infection or any cancer.
- •Patient receiving any IM injection(s) for the co morbid condition and
- •where the IM injection(s) are expected to continue.
- •High grade fever ( >104ºF) or suspected septicemia
- •Hypotension inferred from systolic blood pressure < 90 mmHg
- •Admission in intensive care unit (ICU) or intensive cardiac care
- •unit (ICCU)
- •Severe kidney (creatinine > 2 mg/dl) or liver disease (SGOT &
- •SGPT > 3 times ULN and based on discretion of the investigator)
- •Patients with serum CPK levels > 5 times the ULN for that gender
- •Patients under ongoing treatment with drugs like, statins and fibrates (either alone or in combination), colchicine
- •Thrombocytopenia, defined as platelets less than 50000/μl
- •Consumed > 2.5 gram of Paracetamol within last 24 hours before study drug administration.
研究者
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