CTRI/2019/08/020979尚未招募2 期
Phase II non-randomized open clinical evaluation of Siddha drug VELLI PARPAM for PITHA MOOTHIRA KIRICHARAM (Benign prostate hypertrophy) in Male between 40 to 80 age group attending OPD at AAGHIM attached with GSMC
Govt Siddha Medical College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduced in clinical symptoms using IPSS assessing scale
研究概览
简要总结
This is a Non randomized open clinical trial to study safety and efficacy of siddha drug VELLI PARPAM. The drug is given 130 mg once a day for 48 days. Clinical trial will be started after completion of preclinical and toxicological study. the drug VELLI PARPAM mentioned in siddhar kai kanda marunthu written by Balaramiya. During the trial all the study related data will be recorded and documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Isolated BPH symptoms BPH with lower urinary tract symptoms PSA (prostate specific antigen) with in the normal limit (<4nm/ml).
- •USG prostate volume not more than 75 cc ( stage I – 25 cc to 50 cc and stage II – 50 cc to 75 cc).
排除标准
- •Age < 40 and > 80 yrs male Acute urinary retention CA prostate Acute and chronic renal failure Diabetic nephropathy Post TURP states Stricture urethra Urinary bladder calculus Any severe life threatening illness Nephrotic and nephritic syndrome PSA more than 4 nm/ml [5].
- •USG Prostate volume more than 80CC Acute pyelonephritis Obstructive uropathy Prostatitis.
结局指标
主要结局
Reduced in clinical symptoms using IPSS assessing scale
时间窗: 48 days
次要结局
- Monitoring the reduction in the size of the gland from stage II to stage I and from stage I to normal using ultrasonography(48 days)
研究者
研究点 (1)
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