CTRI/2022/05/042513已完成未知
A prospective, multi-center, randomized, open label, two arm study to evaluate the safety and efficacy of herbal / nutraceutical tablet plus standard of care when compared with only standard of care in patients with benign prostatic hyperplasia (bph)
Arogyaseva Medical Academy of India AMAI0 个研究点目标入组 151 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 151
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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) = 8
- •(moderate to severe BPH at time of randomization)
- •3. Patients having Qmax between 5 ml/sec and 15ml/sec (both
- •included) with minimum voided volume of > 125 ml at the time of
- •randomization.
- •4. Patients having post-voiding residue of < 300 ml as assessed by
- •Ultrasound at randomization.
- •5. Patients and/or his signatory guardian/responsible person had
- •understood the Consent in his own language and willing to follow
- •the suggestion through the assessment period. (i.e. follow up
- •intervals, medicine dose and suggested investigation and
- •examination)
排除标准
- •1. Prostate specific antigen (PSA) greater than 4 ng/ml at screening
- •and randomization.
- •2. Patient with History of neurologic bladder, urethral structures, UTIsymptom, Prostatitis, urologic cancer and prostatic surgery.
- •3. Patient with clinically significant bladder outflow obstruction other
- •than BPH (calculi, tumor or structure) as judged by PI
- •4. Patient undergoing haemodialysis
- •5. Patient who are planning for cataract or glaucoma surgery
- •6. 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 (BP <90/60 mm
- •Hg) / uncontrolled hypertension (=170/100 mm Hg)
研究者
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