An Open Label, Single Arm, Multi-center, Prospective Clinical study to evaluate Efficacy and Safety of WEL/ARNP01 Capsule in patients suffering from Benign Prostate Hyperplasia (BPH) - NI

Welex Laboratories Pvt Ltd0 个研究点目标入组 30 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.Subjects medically diagnosed BPH, having a minimum score of 8 on IPSS and Mild to Moderate Prostatomegaly (weight 25-70 gm) on USG study.
•2.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form

•1.Subjects with clinically significant high PSA levels
•2.Pharmaceutical or medical therapy for BPH or other urological symptoms, history of bladder biopsy and or cystoscopy and biopsy within the last 30 days
•4.Subjects on bladder-training program, indwelling catheter or practiced self-catheterization
•5.Subjects with history of urogenital surgery within the last 6 months;
•6.Subjects with history of chronic persistent local pathology (i.e. interstitial cystitis, bladder stones) within the past 30 days
•7.Subjects receiving/prescribed anticoagulation therapy;
•8.Subjects with severe renal and/or hepatic insufficiency, known genital anatomical deformities, uncontrolled DM and uncontrolled HT, uncontrolled psychiatric disorder, abnormal secondary sexual characteristics and prostatic cancer
•9.Subjects with a history of spinal cord injury, chronic alcohol and/or illicit drug abuse
•10.Subjects participated in any other clinical trial during last 30 days
•11.Any other condition, which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.

发起方

Welex Laboratories Pvt Ltd