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Effect of NiKu plus in reducing fever.

Phase 2
Completed
Conditions
Bacterial and viral infectious agents, (2) ICD-10 Condition: 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

Subjects randomized onto two groups with 24 patients (group 1) and 10 patients (group 2). Group 1 received 1 tablet of  NiKu plus orally after food and monitored for 30 minutes and 1 hour. Group 2 received Paracetamol tablets 500mg after food and monitored for 30 minutes and 1 hour. Measurement of body core temperature from the axilla before the consumption of the study drug, and at 0.5 and 1 hour post dose. Patients who responded to NiKu plus were followed up for 3 days and were asked to take the drug, and provide feedback. If fever persists even after the administration of test drug (NiKu plus), tab.Paracetamol was given as rescue medication.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
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
NameTimeMethod
1.The primary endpoint was defervescence, defined as a core temperature ≤37.1°C (98.7°F).day1,day2,day3
2.The fever reduction was measured after 30 minutes and 1 hour after drug usage.day1,day2,day3
3.Decrease in temperature and patients feedback was recorded.day1,day2,day3
4.The subsequent 2nd and 3rd day the patient was requested to take the drug and provide the feedback.day1,day2,day3
Secondary Outcome Measures
NameTimeMethod
1.Assessing the efficacy with the pre and post values of clinical assessment (Questionnaire based).day1,day2,day3

Trial Locations

Locations (1)

PM Medical Centre Hospital

🇮🇳

Chennai, TAMIL NADU, India

PM Medical Centre Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr Ramesh kannan
Principal investigator
7708925866
srkguruvarshan@gmail.com

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