Health Condition 1: null- For the Treatment of dry cough.
Conditions
Interventions
Intervention1: Test Product: A filmogen glycerol throat spray containing CD-Cyanidin plant premix and one essential oil: A filmogen glycerol throat spray containing CD-Cyanidin plant premix and one es
Sponsors
VITROBIO
Nexus Clinical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMangesh Khadakban
Nexus Clinical Research (India) Ltd.
Outcome results
None listed