Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: Febrex Plus Drop
: twice for three days
Control Intervention1: NIL: NIL
Sponsors
Indoco Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex of age 00 to 02 years [both inclusive] 2. Willing to give written informed consent 3. All patients clinically manifesting with symptoms of common cold & cough
Exclusion criteria
Exclusion criteria: 1) Patients known, or thought to be hypersensitivity to study drug 2) History of auto-immune disease 3) Concurrent use of corticosteroids 4) Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion 5) Participation in other clinical trials the last three months and during study participation 6) Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs 7) Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 8) Patients with galactose or fructose intolerance 9) Patients with severe renal impairment, including those receiving dialysis. 10) Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 11) Patients with preexisting gallbladder disease 12) Active peptic ulcer disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To generate safety data of Febrex Plus DropsTimepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To generate efficacy data of Febrex Plus DropsTimepoint: 5 days | — |
Countries
India
Contacts
Public ContactRahul Hiware
CRO PHARMATRENDZ PRIVATE LIMITED
Outcome results
None listed