Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety & efficacy data of Acebrophylline + Acetylcysteine tablet - NI

Pure and Cure Healthcare Private Limited0 个研究点目标入组 0 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. Patients of either sex of age 18 to 60 years [both inclusive]
•2. Willing to give written informed consent
•3. All patients clinically manifesting with symptoms of Chronic obstructive pulmonary disease (COPD)

•1) Patients known, or thought to be hypersensitivity to study drug
•2) History of auto-immune disease
•3) Concurrent use of corticosteroids
•4) Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or
•may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
•5) Participation in other clinical trials the last three months and during study participation
•6) Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs
•7) Pregnant, lactating women or women of childbearing age who are
•not using an acceptable method of birth control
•8) Patients with galactose or fructose intolerance
•9) Patients with severe renal impairment, including those receiving
•10) Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
•11) Patients with preexisting gallbladder disease
•12) Active peptic ulcer disease

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