Health Condition 1: null- upper respiratory tract infections
Conditions
Interventions
Intervention1: enzymatic formulation of amoxicillin and clavulanic acid (400mg/57mg) oral suspension: oral BD 7days
Control Intervention1: conventional amoxicillin and clavulanic acid (400mg/57mg) ora
Sponsors
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Pediatric Patients aged between 2 to 7 years of age with upper respiratory tract infections like acute otitis media or tonsillitis or sinusitis
Exclusion criteria
Exclusion criteria: ii. Subjects requiring hospitalization iii. Subjects with known or suspected hypersensitivity to penicillins iv. Subjects who have received antimicrobial therapy within 7 days prior to enrollment. v. Patient who severe complications of RTI. vi. Critically ill patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?¼ To evaluate and compare the decrease in severity of clinical signs and symptoms from baseline to Day 3 and Day 7.Timepoint: Day 3 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?¼ The percent change from in safety parameter viz. incidence of Diarrhea at Baseline, 3, and 7 days of treatmentTimepoint: Day 3 and Day 7. | — |
Countries
India
Contacts
Public Contactriddhi Selarka
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Outcome results
None listed