A Randomized, Double-Blind, Two-arm, Study to Evaluate the Anti-Inflammatory Properties, Over all Efficacy and Safety of SAW-1720 in Comparison with Saw Palmetto Oil in the Treatment of Benign Prostate Hyperplasia.

Akay Natural Ingredients Pvt Ltd0 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

暂无简介。

•1.At screening, subject has an International prostatic symptom score greater than 7
•2.BPH subjects with a history of recurrent lower urinary tract infection for at least 2 months
•3.Must be willing and able to give informed consent and comply with the study procedures

•1Has a history of prostate cancer or carcinoma of the prostate or subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
•2Has a residual void volume > 200 ml
•3History of Neurogenic bladder dysfunction, Has bladder neck contracture or urethral stricture,Serious medical co-morbidities like uncontrolled diabetes, hypertension and cardio vascular disorders, neuropathy, liver damage, renal failure or respiratory tract infection.Any prior surgery which could induce dysuria,Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month,Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
•4Subjects allergic to herbal products or any component of the study product
•5Known HIV or Hepatitis B positive or any other immuno-compromised state
•6Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
•7Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study

发起方

Akay Natural Ingredients Pvt Ltd