None listed
Conditions
Interventions
None listed
Sponsors
Emami Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Cohort 1: 1. Clinically diagnosed with common cold 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 Cohort 2- 1. Participants suffering from neck and shoulder pain, sprains, strong knee pain, muscle pain, and joint pain 2. Subjects with pain on VAS scale greater than 40 mm 3. Subjects who willing to sign the written informed consent and ready to comply with the protocol requirement
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1 1. Change in cold symptoms i.e. nasal block, cough, headache, sore throat, runny nose, body ache 2. Number and percentage of participants who report complete relief in headache, cold and body ache Cohort 2 Change in joint and muscle pain on VAS scale Timepoint: Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 Day 3, Visit4 Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1 1. Satisfaction of the quality of sleep 2. Requirement of rescue medications 3. Assessment of skin patch test. 4. Global assessment for overall change by participants and by physician 5. Assessment of adverse events adverse drug reactions including vitals Cohort 2 1. Requirement of rescue medications 2. Assessment of onset of action of Zandu ultra power balm as pain relief 3. Assessment of skin patch test 4. Assessment of duration of action of the Zandu ultra power balm as pain reliever 5. Global assessment for overall change as assessed by participants and investigator 6. Tolerability of study medications as assessed by participants and investigator Timepoint: Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 Day 3, Visit4 Day 7 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt Ltd
Outcome results
None listed