Effect of NiKu plus in reducing fever.
Phase 2
Completed
- Conditions
- Health Condition 1: B95-B97- Bacterial and viral infectious agentsHealth Condition 2: B978- Other viral agents as the cause ofdiseases classified elsewhere
- Registration Number
- CTRI/2018/09/015775
- Lead Sponsor
- Dr JRKs Research and Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
1.Proper written informed consent obtained from the patient before any procedure performed.
2.Adults between the age of 18-75 years with an oral temperature of more than 38.0°C (100.4°F)
3.Patient should have not participated in any other clinical trial during the past 3 months.
Exclusion Criteria
1.History of allergy to any of the drugs in the study
2.Had taken antipyretics within 8 hours
3.Patient who are unable to consume solid and liquid orals.
4.Renal, hepatic or haematological disorders
5.Bronchial asthma, peptic ulcer disease, vomiting
6.Pregnant or lactating women
7.Patients who are unable to sign informed consent.
8.Patient unwilling or unable to comply with study procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The primary endpoint was defervescence, defined as a core temperature �37.1°C (98.7°F). <br/ ><br>2.The fever reduction was measured after 30 minutes and 1 hour after drug usage. <br/ ><br>3.Decrease in temperature and patients feedback was recorded. <br/ ><br>4.The subsequent 2nd and 3rd day the patient was requested to take the drug and provide the feedback. <br/ ><br>Timepoint: day1,day2,day3
- Secondary Outcome Measures
Name Time Method 1.Assessing the efficacy with the pre and post values of clinical assessment (Questionnaire based).Timepoint: day1,day2,day3