Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: Nimesulide Tablets BP 100mg: Nimesulide Tablets BP 100mg, (Nise®, Dr. Reddy’s Laboratories Ltd).
Route of administration is Oral.
Dose frequency as per investigator’s discretion.
Contro
Sponsors
Dr. Reddy’s Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - Male and female patients of age between 18 to 60 years (both inclusive) and who have been recommended either Nimesulide or Ibuprofen plus Paracetamol or Paracetamol alone during their routine clinic visit at the discretion of the investigator. - Patients who are able to understand written and or verbal instructions and are ready to comply with all study requirements with a willingness to participate and ready to give written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: - Contraindications to study medication as per approved label in the country. - Patients who are not fit for the study as per the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Reduction in fever - Body temperature will be evaluated at timepoints. - Reduction in pain - Pain intensity will be evaluated by using self-reported Visual Analogue Scale (VAS) score at timepoints.Timepoint: Fever and pain - Day 0 (0 min, 15 min, 30 min, 1 Hour, 2hour, 4 hour and 6 hour) - Day 1 thereafter once every day till recovery i.e. - EOT maximum up to Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient reported side effects, adverse drug reactions and adverse events of special interest (AESI) like hepatic and renal adverse events will be assessed. - Vital parameters like blood pressure [mm Hg], pulse rate [beats per minute], respiratory rate [breaths per minute] and physical examination will be assessed as additional safety parameters.Timepoint: - Day 0 - Day 1, till recovery - EOT maximum up to Day 10 | — |
Countries
India
Contacts
Public ContactDr Manish Rajak
Dr Reddys Laboratories Limited
Outcome results
None listed