CLINICAL TRIAL STUDY TO EVALUATE EFFICACY AND SAFETY OF FILMOGEN GLYCEROL THROAT SPRAY CONTAINING CD-CYANIDIN PLANT PREMIX WITH ESSENTIAL OI
- Conditions
- Health Condition 1: null- For the Treatment of dry cough.
- Registration Number
- CTRI/2016/08/007153
- Lead Sponsor
- VITROBIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 63
Both male and female, Age between 8 to 65 years old.
Patients having dry cough (less than 7 days) of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present) (absence of bronchial mucus/phlegm production)
Not under any antibacterial or antiviral treatment before recruitment.
Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational Product for the treatment of the studied condition during the study period (except in cases when patientâ??s condition worsens as per study physician. In this case, Study physician will decide to prescribe antibiotic, if required).
Ready to abstain from administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters, tea, coffee.
Cooperative and understanding skills.
Hypersensitivity/ history of allergy to any of the Investigational productâ??s components.
Patients who had taken any medicated confectionary, throat pastille, spray or any product with demulcent properties, any cough medicines or drugs containing antihistamines within last 72 hours prior to screening.
Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough
Patients with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
Patients who had used any local anesthetic within the past 24 hours.
Patients who have used a longer acting or slow release analgesic during the previous 24 hours.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: <br/ ><br>ï?§Change in the dry cough severity and frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline. <br/ ><br>Timepoint: Frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ï?§Change in score of throat pain, throat irritation, throat mucosa redness, swollen throat, fever and effect on swallowing at 5 minutes and 2 h after the 1st application on the days 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to baseline values and compared to the placebo treatment.Timepoint: Effect on swallowing at 5 minutes and 2 h after the 1st application