Clinical Study of fixed dose combination of FLUCOLD TABLET in the Treatment of common cold and flu in adult populatio
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2020/07/026402
- Lead Sponsor
- Wallace Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 199
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Assess the symptomatic relief of common cold and flu syndrome <br/ ><br>2. Significant changes in VAS scores from baseline to EOT <br/ ><br>3.Tolerance of IP <br/ ><br>4. Assessment of safety of Investigational product <br/ ><br>I.Adverse event <br/ ><br>II.Physical examination <br/ ><br>III.Biomarker of systemic safety <br/ ><br>Timepoint: baseline Day 1, Day 4 and Day 9