Health Condition 1: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Akums Drugs and Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex of age 06 to 12 years [both inclusive] 2. Willing to give written informed consent 3. All patients clinically manifesting with symptoms of Lower respiratory tract infection
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) Patients with galactose or fructose intolerance 8) Patients with severe renal impairment, including those receiving dialysis. 9) Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 10) Patients with preexisting gallbladder disease 11) Active peptic ulcer disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this PMS is to evaluate safety & tolerability of this FDC in treatment of lower respiratory tract infections in children in the actual field conditions of use.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary objective of this PMS is to evaluate efficacy of this FDC in treatment of lower respiratory tract infections in children in the actual field conditions of use.Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactMamta Sharma
CRO PHARMATRENDZ PRIVATE LIMITED
Outcome results
None listed