Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: FLUCOLD TABLET: One tablet four hourly for three days
Control Intervention1: Not applicable: Not applicable
Sponsors
Wallace Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female having the age of 18 to 55 years. 2.Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions: The common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points 3. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Patients who are not willing to give written informed consent. 2.Any known hypersensitivity to the study products. 3.Pregnant and lactating women. 4.Any history of seasonal or perennial allergic rhinitis. 5.Patients who have taken treatment for the presenting symptom within 7 days of screening. 6.Any history of drug abuse /chronic alcoholism 7.Use of monoamine oxidase inhibitors or barbiturates 8.Use of Vitamin C/ascorbic acid or taking supplements or fruits rich in vitamin C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Incidence rates of Treatment â?? emergent adverse events (TEAEs) and serious adverse events (SAEs).Timepoint: baseline Day 1, Day 4 and Day 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess the symptomatic relief of common cold and flu syndrome 2. Significant changes in VAS scores from baseline to EOT 3.Tolerance of IP 4. Assessment of safety of Investigational product I. Adverse event II. Physical examination III. Biomarker of systemic safety Timepoint: baseline Day 1, Day 4 and Day 9 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed