Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: ZincorespTM Syrup: ZincorespTM Syrup (5 ml) syrup twice a day for 8 weeks
Control Intervention1: NA: NA
Sponsors
apex laboratories private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children between 2-12 years of age of any gender. 2. Children having recurrent episodes of any of the following: - Fever associated with respiratory tract infections (RTI) - URTI (rhinitis, pharyngitis, laryngitis, otitis media, influenza) - LRTI (pneumonia, bronchitis, and bronchiolitis) - Bronchial asthma - COPD - SARS-CoV-2 - Combined allergic rhinitis and asthma syndrome (CARAS) - Pulmonary tuberculosis 3.Parents are willing to give consent for the child’s participation in study.
Exclusion criteria
Exclusion criteria: 1. Any evidence of malignancy. 2. History and clinical findings suggestive of metabolic diseases 3. History and clinical findings suggest chronic respiratory tract diseases including interstitial lung disease (ILD) and cystic fibrosis. 4. History of respiratory tract surgery. 5. Known diagnosis of congenital cardiac defects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in symptoms of respiratory disorders and/or infectionsTimepoint: Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator global assessment for efficacyTimepoint: Week 12;Investigator global assessment for safety and tolerabilityTimepoint: Week 12;Number of days of hospitalization required during the study period.Timepoint: Baseline to Week 12;Time required to recover completely from infection during the study period.Timepoint: Baseline to Week 12;Total number of children experiencing at least one episode of fever during the study period.Timepoint: Baseline to Week 12;Total number of children not having any episode of respiratory tract infections (URTI or LRTI) or exacerbations of existing conditionsTimepoint: Baseline to Week 12;Total number of children requiring antimicrobial agents (antibiotics and antiviral drugs) during the study period. Timepoint: Baseline to Week 12;Total number of children requiring hospital admission, but not requiring supplemental oxygen during the study period.Timepoint: Baseline to Week 12;Total number of children requiring hospital admission, requiring supplemental oxygen during the study period.Timepoint: Baseline to Week 12;Total number of children with at least one episode of lower respiratory tract infections (pneumonia, bronchitis, and bronchiolitis)Timepoint: Baseline to Week 12;Total number of children with at least one episode of upper respiratory tract infections (rhinitis, pharyngitis, laryngitis, otitis media, and influenza)Timepoint: Baseline to Week 12;Total number of children with Bronchial asthma, Combined allergic rhinitis and asthma. syndrome (CARAS).Timepoint: Baseline to Week 12;Total number of days of work lost by the parents due to the child’s illness during the study period.Timepoint: Baseline to Week 12;Total number of episodes of infections lasting more than 7 days during the study period.Timepoint: Baseline to Week 12 | — |
Countries
India
Contacts
Public ContactDr Vaishali Thakare
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
Outcome results
None listed