Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: ZincorespTM Syrup or
ZincorespTM Tablet: ZincorespTM Syrup (5 ml syrup Once a day /twice a day).
Or ZincorespTM Tablet (1 tablet Once a day /twice a day) for 8 weeks
Control Interventi
Sponsors
apex laboratories private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age above 2 years of any gender. 2. Patients having recurrent episodes of any of the following: - Fever associated with respiratory tract infections (RTI) - URTI (rhinitis (Acute/allergic/Nonallergic), Common cold, Sinusitis, pharyngitis, laryngitis, influenza) - SARS-CoV-2 - Combined allergic rhinitis and asthma syndrome (CARAS) - Acute otitis media, - titis media with effusion, - Chronic suppurative otitis media 3. Patients and parents who are willing to give consent for their or the child’s participation respectively 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 ear, nose, throat, and 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;Patient global assessment for efficacyTimepoint: Week 12;Patient global assessment for safety and tolerabilityTimepoint: Week 12;Time required to recover completely from infection during the study period.Timepoint: Baseline to Week 12;Total number of days of work lost by the patients due to 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;Total number of patients experiencing at least one episode of fever during the study period.Timepoint: Baseline to Week 12;Total number of patients not having any episode of respiratory tract infections (URTI) or exacerbations of existing conditions during the study period.Timepoint: Baseline to Week 12;Total number of patients requiring antimicrobial agents (antibiotics and antiviral drugs) during the study period.Timepoint: Baseline to Week 12;Total number of patients requiring hospital admission, but not requiring supplemental oxygen during the study period.Timepoint: Baseline to Week 12;Total number of patients requiring hospital admission, requiring supplemental oxygen during the study period.Timepoint: Baseline to Week 12;Total number of patients with at least one episode of Acute otitis media, Otitis media with effusion, Chronic suppurative otitis mediaTimepoint: Baseline to Week 12;Total number of patients with at least one episode of upper respiratory tract infections (rhinitis, Common cold, Sinusitis, pharyngitis, laryngitis, otitis media, and influenza)Timepoint: Baseline to Week 12;Total number of patients with Combined allergic rhinitis and asthma syndrome (CARAS).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