Parallel arm, prospective, randomized study for clinical effectiveness of TR-01 in providing relief in productive, non-productive and chronic bronchial cough with throat irritation. - NI

MN Pharmaceuticals0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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

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