Health Condition 1: J208- Acute bronchitis due to other specified organisms
Conditions
Interventions
None listed
Sponsors
Dabur Research and Development Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female subjects between 12 and 50 years of age and diagnosed as having dry cough less than 14 days of any origin acute moderate to severe wet productive cough of a maximum of 14 days before screening of any origin, and chronic bronchitis will be included in the study. 2) Participants must be willing to commit to medication dosing and assessment visits for evaluation. 3) Participants must be willing to refrain from taking any other medications for the treatment of cough. 4) Subjects presenting symptoms of throat pain, throat redness, and throat irritation/itching, and not under any antibacterial or antiviral treatment before recruitment, will be selected for the study. 5) Subjects willing and able to provide signed written informed consent before any study- specific procedure, and subjects who, in the opinion of the investigator, will be able to comply with the study requirements, will be selected for the study.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of underlying lung pathology such as lung abscess, cancer, or cystic fibrosis. 2) Subjects with known hypersensitivity to any ingredients of the investigational product. 3) Subjects with a history of myocardial diseases within 4weeks before enrolment, and a history of hepatic impairment. 4) Subjects with known human immunodeficiency virus (HIV), Hepatitis B virus, Hepatitis C virus, or tuberculosis infection. 5) Subjects having a history of alcohol, smoking, or drug abuse. 6) Subjects currently on any other herbal therapy or supplement for cough. 7) Subjects who are pregnant, lactating, or female subjects not using acceptable contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of test compounds i.e. DRDC/2025/028 and DRDC/AY/8070 with respect to symptomatic relief in patients suffering from cough, change in the wet cough severity and frequency score, change in the dry cough severity and frequency.Timepoint: at baseline, 4 weeks & 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in the chest discomfort score, change in score of throat pain, change in throat irritation/itching, throat mucosal redness, fever, measure of drowsiness, physician s global assessment of efficacy, subject s global assessment of efficacy, and chest X-ray analysis from baseline to end of treatment (only with history of bronchial cough).Timepoint: for 14 days | — |
Countries
India
Contacts
Public ContactDr Baidyanath Mishra
Dabur India Ltd.
Outcome results
None listed