Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: TR-01 cough syrup
: 10ml thrice a day for minimum 4 and maximum 8 days
Control Intervention1: NIL: NIL
Sponsors
MN Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females between 18 to 65 years age. 2. Patients diagnosed as having cough with one of the following conditions a. Patients having dry cough (less than 14 days) of any origin b. Patients having acute moderate to severe wet (productive) cough production at a maximum of 14 days prior to screening of any origin c. Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for one consecutive months for more than two consecutive years). 3. Presenting symptoms of Throat Pain, throat redness, Throat irritation/itching, (Fever if present). 4. Not under any antibacterial or antiviral treatment before recruitment. 5. Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational 6. 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). 7. 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. 8. Patient willing and able to provide a signed written informed consent prior to any study â?? specific procedure. 9. Patients who in opinion of the investigator will be able to comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis. 2. Patients with known hypersensitivity to ingredients of Investigational Products 3. Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment 4. Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease. 5. Patients with uncontrolled Hypertension. 6. Alcohol, smoke and drug abusers will be excluded. Occasional users of cigarettes and alcohol may participate in the study as per the investigators discretion. Such participants should be instructed from restricting the use of cigarettes / alcohol during the study participation period. 7. Subjects on any other herbal therapy / supplement for cough 8. Patients with history of hepatic impairment 9. Pregnancy, lactation and female patients not using acceptable contraceptive measures. 11. Participation in another clinical trial in the past 3 months 10. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of herbal syrup with respect to symptomatic relief in patient suffering from cough. Change in the wet cough severity and frequency score Change in the dry cough severity and frequency score Change in the bronchial cough severity and frequency scoreTimepoint: At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Leicester Cough Questionnaire Change in the Chest discomfort score Change in score of throat pain Change in throat irritation/itching Throat mucosa redness Fever Measure of drowsiness Physicianâ??s global assessment of efficacy Subjectâ??s global assessment of efficacy Chest X-ray analysis from baseline to end of treatment (brochial cough only) Safety assessed by Adverse EventsTimepoint: At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline. | — |
Countries
India
Contacts
Public ContactMr Ashish Nagaonkar
Mprex Healthcare
Outcome results
None listed