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.Subject in an early stage of a common cold with symptoms evidenced less than 48 hours. TSS at baseline less than 9 and a score of greater than 1 for at least one of the following symptoms: sore throat, runny nose or blocked nose. 2.Subject who agrees to refrain from taking any products intended to prevent, intervene in, or treat cough, colds, flu during the study period. 3. Female subject who is non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. 4. Subject willing to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with History of Clinically significant Disorder 2.Subject having tested positive for SARS-CoV-2 by Rapid antigen testing on a nasopharyngeal or oropharyngeal swab during the screening visit. 3.Subjects who test negative for viral load (Rhino virus, Influenza A, B, Human Coronavirus) at baseline. 4.Subjects categorized with severe symptoms. 5. Subject having taken influenza vaccination within the last 3 months prior to Screening visit. 6.Subject having common cold or flu like symptoms for more than 48 hours. 7. Subject under regular use of products that may influence the study outcome 8. Pregnant and lactating women. 9. Subjects allergic to herbal products or any component of the study product. 10. Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 11.Any additional conditions that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
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/Day 3/ Day 4/Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in efficacy parameters including Questionnaire based assessments at different time points up to 21 daysTimepoint: Day 1,Day 4, Day 5,Day 6, Day 7,Day 14, Day 21;Over all safety of the ProductTimepoint: Day 1 to Day 21;Percent of individuals with relapse post-interventionTimepoint: Up to Day 21 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed