In patients suffering from acute or chronic Rhino-sinusitis
Not Applicable
- Conditions
- Health Condition 1: null- In Patients Suffering From Acute or Chronic Rhino-Sinusitis.
- Registration Number
- CTRI/2017/03/008016
- Lead Sponsor
- VITROBIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 63
Inclusion Criteria
Patients with complain of clinical manifestations of Rhino-sinusitis (RS) Major symptoms (rhinorrhea
(anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure), with a
minimum Rhino-sinusitis severity (RSS) score of 25 out of 50.
Exclusion Criteria
Hypersensitivity to any of the Investigational productâ??s components.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean of overall major symptoms score (sum of all symptoms of rhinorrhea (anterior nasal <br/ ><br>discharge), postnasal drip, nasal congestion, headache, facial pain/pressure scores)Timepoint: from baseline to 30 <br/ ><br>minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery
- Secondary Outcome Measures
Name Time Method Change in individual symptoms score of rhinorrhea (anterior nasal discharge), postnasal drip, nasal <br/ ><br>congestion, headache, facial pain/pressure scores) from baseline to 30 minute post 1st dose initiation on <br/ ><br>day 1, day 2, day 3, day 6, day 15 or day of recovery (Timepoint: rom baseline to 30 <br/ ><br>minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery;Proportion of patients requiring antibiotics in Test group as compared to placebo group.Timepoint: from baseline to 30 <br/ ><br>minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery