None listed
Conditions
Interventions
None listed
Sponsors
Emami Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed with common cold defined by clinical evaluation and presence of at least two or more of the following symptoms nasal block, cough, headache, sore throat, runny nose, body-ache, chills classified as moderate to severe category 2. Beginning of the symptoms of common cold in a minimum period of 24 hours and a maximum of 72 hours prior to baseline visit. 3. Willing to comply with all requirements of the study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cold symptoms i.e. nasal block, cough, headache, sore throat, runny nose, body-ache, chills Timepoint: Day 0, Day 3 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of subjects relieved completely from symptoms of cold 2. Assessment of headache on VAS 3. Assessment of onset of action, duration of action, and relief period of cold symptoms and headache 4. Assessment of onset of action, duration of action of counter-irritancy and cooling effects 5. Satisfaction of the quality of sleep 6. Requirement of rescue medications 7. Skin patch test using Dermal Response Score. 8. Global assessment for overall change by participants and by physician 9. Adverse events, adverse drug reactions including vitals Timepoint: Day 0, Day 3 and Day 7 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed