A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of ProPlus Capsules in Subject suffering with Benign Prostatic Hyperplasia (BPH) - NI

M/s Synthite Industries Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

暂无简介。

•1 Male Patients of age between 18 years to 65 years both inclusive who are diagnosed case of benign Prostatic Hyperplasia
•2 Patients having International Prostate Symptom Score IPSS greater than or equal to 8 moderate to severe BPH at time of enrollment
•3 Patients having Qmax between 5 ml per sec and 15ml per sec both included with minimum voided volume of greater than 125 ml at the time of Screening
•4 Patients having post voiding residue PVR of less than 300 ml as assessed by Ultrasound at screening
•5 Patient is willing to give Informed Consent

•1 Prostate specific antigen (PSA) beyond 4 ng per mL at screening and enrolment
•2 Patient with history of neurologic bladder urethral strictures urinary tract infections prostatitis urologic cancer and prostatic surgery
•3 Patient with clinically significant bladder outflow obstruction other than BPH (calculi tumour or stricture) as judged by Investigator
•4 Clinical evidence of any other bladder or urinary tract conditions which may affect lower urinary tract symptoms at screening
•5 Patient undergoing hemodialysis
•6 Patient who are planning for cataract or glaucoma surgery
•7 Patients with history of cardiovascular disease
•including but not limited to
•History of Myocardial Infraction within the last 90 days
•History of angina
•History of congestive cardiac failure
•History with uncontrolled arrhythmias hypotension Blood Pressure less than 90 per 60 mm Hg uncontrolled hypertension greater than or equal to 170 per 100 mm Hg

发起方

M/s Synthite Industries Private Limited