Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: POLYHERBAL PEDIATRIC ORAL DROPS (Zeal® Kid Drops): Age 3 months -1 yrs: 0.5 ml i.e. 10 drops: 3 times
a day,in day for 7 days with 6 -8 hrs gap between two consecutive dose by oral rou
Sponsors
Vasu Research Centre A Division of Vasu Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Willing to provide written informed consent for participation in the study and adhere to the protocol requirements by parent. Children of either sex having age group 3 months - 6 years (both inclusive). Children presenting with symptoms of acute common cold prevailing for less than 48 hours. Parentâ??reported nasal congestion severity score equating to stuffy or very stuffy (score 3 or 4 on a 5â??point categorical scale 0 [not stuffy at all] 1 [a tiny bit stuffy] 2 [a little stuffy] 3 [stuffy] 4 [very stuffy])Parents reporting of children having at least 2 of the following cold symptoms running nose, sneezing, sore throat, headache, body ache, Pyrexia and/or cough
Exclusion criteria
Exclusion criteria: Hypersensitivity to any of the components of formulation or the excipients of the formulation. Signs or symptoms of a more treatable disease (e.g. asthma, pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis). Children who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, or other medications that are expected to alleviate cold symptoms, or those who have taken food that is expected to relieve cold symptoms within one week of the start of the study Children with other than acute cough ( >2 weeks). History of reactive airways disease, asthma, or chronic lung disease. Any condition that in opinion of the Investigator, does not justify the subjectsâ?? participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weighted sum of the change from baseline (baseline minus post baseline) in the instantaneous nasal congestion severity score over the first 8 hours of treatment on day 1.Timepoint: Baseline and Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| The nasal congestion severity relief score at 6 and 12 hours on day 1, 3 and 7. The Nasal symptom and function composite score at 6 and 12 hours on day 1, 3 and 7. Overall Investigator Global assessment on Day 7 Treatment emergent AE or SAE Sleepiness assessment with Maldonado scaleTimepoint: Day 1,3,7 | — |
Countries
India
Contacts
Public ContactMr Nimesh Parekh
COD Research Pvt Ltd
Outcome results
None listed