Health Condition 1: J09-J18- Influenza and pneumonia
Conditions
Interventions
Intervention1: Hariras Ayurvedic pills: One Hariras Ayurvedic pills 08 to 10 times per day for five days
Control Intervention1: NIL: NIL
Sponsors
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects (18 to 65 years of age) with history of acute nonproductive cough and throat irritation for less than 1week duration 2. Subjects with a cough score of 0, 1, or 2 during daytime 3. Subjects willing and able to provide signed informed consent forms before any study-related procedures. 4. Subjects willing to abstain from other medication (allopathic or herbal) for cough treatment during the study period 5. Subjects who in the opinion of the Investigator will be able to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, and Whooping cough. 2. Subjects with a history of Chronic Obstructive Pulmonary Diseases, Asthma 3. Subjects with a history of underlying lung pathology such as lung abscess, or cystic fibrosis. 4. Subjects with known hypersensitivity to any ingredients of the investigational products 5. Subjects with clinical suspicion of any systemic bacterial infection. 6. Subjects with a history of Myocardial Infarction (MI) within 4 weeks before enrollment 7. Subjects with immediate life-threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease. 8. Subjects who had received any sedative, hypnotic or tranquilizer within 14 days before randomization 9. Subjects who had received any of the anti-histamines, cough suppressants, mucolytics, expectorants, or antibiotics within 3 days before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in day and night frequencies of cough from Baseline to end of treatment period on a 6-point scale 2. Change in throat irritation from Baseline to end of treatment period on a 5-point scale Timepoint: At Screening, Baseline, Day 1, Day 2, Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to relief from cough & throat irritation on a 5-point scale for first morning dose over a treatment period of 05 days 2. Duration of relief from symptoms (related to acute nonproductive cough) on a 5-point scale for first morning dose over a treatment period of 5 days 3. Measure of drowsiness on a 2-point scale Timepoint: At Screening, Baseline, Day 1, Day 2, Day 5 | — |
Countries
India
Contacts
Public ContactMr Manish Jayatilal Bhardwaj
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.
Outcome results
None listed