Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: Hypertonic saline gargling: This will be the intervention group or Group A
Patients will be made to gargle with 3% hypertonic saline, more than 3 times daily, for five days, or until c
Sponsors
Post Graduate Institute of Medical Education & Research, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Children from 4-12 years of age with upper respiratory tract infection (as defined below), who are capable of gargling, to be determined by demonstration in the OPD. Definition of URTI: “Presence of at least two respiratory symptoms such as nasal congestion (runny nose, stuffy nose), cough, sore throat OR a respiratory symptom plus at least one systemic symptom (Low energy/tired, muscle aches/pains, headache, fever =38°C) ?.
Exclusion criteria
Exclusion criteria: 1. Children who are unable to gargle. 2. SARS-CoV2 PCR positive children 3. Children with: a. Known pre-existing chronic respiratory disease viz. cystic fibrosis, pulmonary or extrapulmonary tuberculosis, bronchiectasis. b. Allergic rhinitis c. Known aero-digestive disorders such as gastro-esophageal reflux disease. d. Immunosuppression for any reason. e. Known primary or secondary immune deficiency. 4. Children taking part in any other trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for resolution of URTI.Timepoint: This will be defined as the time taken (in days) for resolution of all symptoms of the URI episode from the time of randomization Severity of illness will be assessed by the WURSSK score that will be scored by the parents/children on a daily basis. Score will be recorded at enrollment upto the time of resolution or 14 days whichever is earlier Resolution is defined as the WURSSK score being 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Discontinuation of study medicationsTimepoint: subjective as per reasons stated by patient within 14 days or resolution of symptoms;Need for contacting healthcare professionalTimepoint: Number of times contacted within 14 days or resolution, whichever earlier;Number of days lost from schoolTimepoint: Within 14 days or upto resolution of symptoms;Number of days lost from work for parentsTimepoint: days lost within 14 days or upto resolution of symptoms of child;Parental assessment of severityTimepoint: Based on WURSSK score, 14 days or resolution whichever earlier;Perceived adverse eventsTimepoint: Number & type of adverse events within 14 days or resolution, whichever earlier;Resolution of symptomsTimepoint: 14 days or resolution whichever earlier | — |
Countries
India
Contacts
Public ContactDr. Joseph L Mathew
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed