Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: Advanced Formulation of FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet: Take one tablet thrice daily of advanced Formulation of
Sponsors
Indoco Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 to 60 years 2.Patients with Modified Jacksons Score of greater than 6 at screening. 3.Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours. 4.Willing to use effective contraception during the study period (if applicable). 5.Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Allergy to any study medication 2.History of asthma, sinusitis, or chronic respiratory disorders 3.Recent use of cold or allergy medications (less than 24 hours) 4.Participation in another clinical trial within the past 30 days. 5.Any condition that, in the investigators judgment, may compromise safety, compliance, or study integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in modified Jackson s scoreTimepoint: At Day 3 and 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first noticeable relief after using study DrugTimepoint: Day 0 to Day 5;Patient Satisfaction ScoreTimepoint: At Day 3 and 5.;Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drugTimepoint: Day 0 to Day 5 | — |
Countries
India
Contacts
Public ContactDr Abhijit Anil Trailokya
Indoco House, 166 CST Road, Santacruz (E)
Outcome results
None listed