A double blind, single centric, randomized placebo-controlled study to demonstrate the efficacy and tolerability of an oral product in the management of symptoms of cough in comparison to placebo.

Giellepi Spa0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Patient should be able to give written informed consent.
•2.Diagnosis of persisting cough (Cough Clinical Score of 3)
•3.Males and females, 18-65 years of age (both inclusive)
•4. Ability to comply with requirements of trial.
•4.Persisting cough (at least 7 days up to 3 weeks, not treated with any antitussive product)

•Subjects having TB, COPD or Asthma, pulmonary fibrosis, lung cancer or chest X-ray showing lung problems.
•2. Known history of drug or alcohol abuse.
•3. Subjects who, in the opinion of the investigator, are mentally
•incapacitated such that informed consent cannot be obtained.
•4. Pregnant and lactating women.
•5. Subjects with clinically significant history of co-morbid condition
•(like, diabetes, immunodeficiency, HIV, HPV) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
•6. Patients suffering from any condition which in opinion of the Investigator may interfere with the outcome for the study.
•Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease.
•8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values >= 2.5 X Upper Limit of Normal (ULN), Serum creatinine of >= 1.5 mg/dL.
•9. Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
•10. Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial.
•11. Known hypersensitivity to, or intolerance of, study products or their formulation excipients

发起方