Health Condition 1: null- For the Treatment of wet (productive) cough
Conditions
Interventions
Intervention1: Test Product: A filmogen glycerol throat spray containing, Solagum, CW-Cyanidin plant premix & an essential oil: The product contains filmogen glycerol as the main active ingredient alo
Sponsors
VITROBIO
Eligibility
Inclusion criteria
Inclusion criteria: Both male and female, Age between 08 to 65 years old. Patients having acute moderate to severe wet (productive) cough (onset of bronchial mucus production at a maximum of 7 days prior to screening of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present). 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 if patientâ??s condition worsen (At the discretion of study physician antibiotic will be prescribed 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. Those who had taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties, expectorants, mucolytic drug, any cough medicines or drugs containing antihistamines within last 72 hours prior to screening and during study. Participants with unproductive cough (dry cough) 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. Patients taking antibiotics during the previous 14 days. Patients with a history of severe renal impairment, hepatic impairment. Patients with a history of alcohol abuse or who stated that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol greater than 21 units per week for females and greater than 28 units per week for males). Patients unable to refrain from smoking during their stay in the investigative site. Patient who is pregnant, nursing, or a woman of childbearing potential not practicing adequate contraception. Women, who are uncertain if they are pregnant, may participate in the study, if they undergo a pregnancy test, which shows a negative result.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the wet cough severity score Timepoint: Two hours | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?§ Change in score of throat pain, throat irritation/itching, throat mucosa redness, fever at 5 minutes and 2 h after the 1st application on the 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 baseline.Timepoint: 2 h after the 1st application on the 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 baseline.;ï?§ Change in the Chest discomfort score, Change in the color of expectorated sputum, Consistency of sputum, at 2h after the start of treatment on the day 1, day 2, day 3, day 6, day 9, day 12, day 15 or up to complete recovery (whichever is earlier) compared to baseline.Timepoint: 2h after the start of treatment on the day 1, day 2, day 3, day 6, day 9, day 12, day 15 or up to complete recovery (whichever is earlier) compared to baseline. | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd
Outcome results
None listed