Safety and Efficacy study of Nasal Spray on Children and Adolescents with common cold
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2022/12/048270
- Lead Sponsor
- ITC Life Sciences and Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects with common cold symptoms.
2.Subjects with cold symptom severity within the specified score range.
3.Subject who agrees to give informed consent / assents and comply with the study procedures.
1. Subjects with history/presence of clinically significant condition/disorder/allergy to herbal products (self-reported), or regularly consuming certain products as per invetigator judgement could interfere with the results of the study or the safety of the subject.
2. Subjects tested positive for SARS-CoV-2 by Rapid Antigen Test.
3. Subjects who test negative for viral load at baseline.
4. Subjects with co-existing bacterial/secondary infections.
5. Subjects having taken influenza vaccination within the last 3 months prior to screening visit.
6.Subjects having common cold or flu like symptoms for > 48 hours.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Total Symptom Score (TSS) and Viral Load at different time points in treatment arm in comparison with Baseline and comparatorTimepoint: Day 2/ 3/ 4/ 5/ 7
- Secondary Outcome Measures
Name Time Method Mean change in efficacy parameters including Questionnaire based assessments at different time points up to 21 daysTimepoint: Upto Day 21;Overall product safetyTimepoint: Upto Day 21;Percent of individuals with relapse post interventionTimepoint: Upto Day 21