Health Condition 1: null- Patients with acute non productive cough and throat irritation for less than 1 week duration and age range is 18 - 65 years
Conditions
Interventions
Intervention1: Honitus Syrup: Ayurvedic Formulation: Dose, duration and frequency of the same are 10 ml ( 2 teaspoonful) orally 4 times a day for a period of 3 days
Control Intervention1: Benadryl Cou
Sponsors
Dabur India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with H/O acute non productive cough and throat irritation for less than 1 week duration 2. Males and Females between 18-65 years age. 3. Patients who in the opinion of the Investigator will be able to comply with the study requirements. 4. Patients with a cough score of 0, 1 or 2 during day time 5. Patients willing and able to provide signed informed consent form prior to any study related procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with H/O lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, Whooping cough. 2. Patients with H/O Chronic Obstructive Pulmonary Diseases/Asthma 3. Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis. 4. Patients with known hypersensitivity to ingredients of Investigational Products 5. Patients with clinical suspicion of any systemic bacterial infection. 6. Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment 7. Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease. 8. Patients with Hypertension on Angiotensin-converting enzyme (ACE) inhibitors. 9. Alcohol, smoke and drug abusers will be excluded. Occasional users of cigarettes and alcohol may pariticpate in the study as per the investigator?s discretion. Such participants should be instructed from restricting the use of cigarettes / alcohol during the study participation period. 10. Patients participating in any other clinical trial. 11. Pregnant or lactating females. 12. Patients who have received any immunosuppressant, Sedative, Hypnotic or Tranquilizer 14 days prior to enrollment. 13. Patients who have received any Anti Histaminics, Cough suppressants , Mucolytics , Expectorants or Antibiotics 3 days prior to enrollment. 14. Any other condition due to which patients are deemed to be unsuitable by the Investigator for reason (s) not specifically stated in the exclusion criteria. 15. Patients with H/O Parkinson?s disease who are on Mono Amine Oxidase Inhibitors (MAO) inhibitors. 16. Any psychiatric illness which may impair the ability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in day and night frequencies of cough from baseline on a 6 point scale in patients with acute non- productive cough receiving therapy over a period of 3 days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of 3 daysTimepoint: Changes in day and night frequencies of cough from baseline on a 6 point scale in patients with acute non- productive cough receiving therapy over a period of 3 days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of 3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physicianâ??s global assessment of efficacy on a 5 point scaleTimepoint: Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physicianâ??s global assessment of efficacy on a 5 point scale | — |
Countries
India
Contacts
Public ContactDr Deepak Deshmukh
Dabur India Ltd.
Outcome results
None listed