Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
None listed
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed