A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of JACKPROTM in comparison to placebo in the treatment of benign prostate hyperplasia and androgen deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean Change in Post-voidal residual volume of urine and change in Questionnaire based assessments
研究概览
简要总结
Thisis a double blind, randomized (1:1), placebo controlled, parallel group, twoarm, single center study. Elderly male subjects meeting all inclusion and noexclusion criteria after signing a written informed consent will be enrolled inthe study. After passing the eligibility criteria, subjects will be randomizedinto 2 treatment arms to receive JACKPROTM or placebo in 1:1 ratio.Thesubject will arrive at the study site in a fasting state and blood samples willbe collected for laboratory assessment and questionnaire based assessments will be performed.Thestudy is planned to be conducted in 3 visits over a period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.At screening, subject has IPSS score greater than 7,AMS score greater than 27 and ADAM questionnaire items 1 or 7 or any 3 other questions as positive 2.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Has a history of prostate cancer or carcinoma of the prostate or Subjects with known history of serum PSA concentration greater than 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
- •2.Has a residual void volume greater than 250 mL 3.History of Neurogenic bladder dysfunction or bladder neck contracture or urethral stricture r acute or chronic prostatitis or urinary tract infection or Serious medical co-morbidity including Haematuria diabetes,any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH,or associated symptoms and Erectile Dysfunction in past 1 month or Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months 4.Subjects allergic to herbal products or any component of the study product 5.Known HIV or Hepatitis B positive or any other immuno-compromised state 6.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 7.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean Change in Post-voidal residual volume of urine and change in Questionnaire based assessments
时间窗: Day 0, Day 42, Day 84
次要结局
- Mean change in uroflowmetry parameters(Day 0, Day 84)
- Mean change in the male hormonal markers(Day 0, Day 84)
- Mean change in Quality of Life Questionnaire(Day 0, Day 42, Day 84)