Randomized Control Trial To Determine The Use And Safety of Hypertonic Saline Gargling In Acute Upper Respiratory Tract Infections in Childre
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2023/11/059420
- Lead Sponsor
- Post Graduate Institute of Medical Education & Research, Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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) ?.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br> <br/ ><br>Severity of illness will be assessed by the WURSSK score that will be scored by the parents/children on a daily basis. <br/ ><br> <br/ ><br>Score will be recorded at enrollment upto the time of resolution or 14 days whichever is earlier <br/ ><br> <br/ ><br>Resolution is defined as the WURSSK score being 0 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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