NCT07065682招募中1 期
Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Uroflowmetry result
研究概览
简要总结
This study is a double blinded RCT with pre-post test design on the effect of combination of dutasteride and aloe vera, compared to dutasteride only, on uroflowmetry results, prostate volume, and VEGF serum level among patients with benign prostate hyperplasia. The treatment was given for 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with BPH clinically or radiologically (prostate volume > 30 gram, Qmax <15 mL/s)
- •Willing to participate to the study
排除标准
- •Clinically or radiologically suspected of having prostatic cancer
- •Previous prostatic surgery
- •Patients with urinary retention
- •Patients with BPH complications: urinary tract infections, urolithiasis, or hydroneprhosis
- •Previously consumed alpha blocker or 5ARI in the last 6 months
- •Have consumed aloe vera extract routinely
研究组 & 干预措施
Dutasteride 0,5 mg/day + Aloe Vera Extract 380 mg/day
Experimental
干预措施: Aloevera + dutasteride (Drug)
Dutasteride
Active Comparator
Control
干预措施: Dutasteride (0.5mg) (Drug)
结局指标
主要结局
Uroflowmetry result
时间窗: 12 weeks
Qmax of Uroflowmetry result
次要结局
- Prostatic volume(12 weeks)
- VEGF(12 weeks)
研究者
Achmad Rizky Herda Pratama
dr. Achmad Rizky Herda Pratama, Sp.U, S.H.
Universitas Diponegoro
研究点 (1)
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