CTRI/2023/07/054658尚未招募2 期
A comparative clinical study to evaluate the efficacy of Ksharapippali and Mahodarahara kashaya in Vatashteela with special reference to Benign Prostatic Hyperplasia
未提供1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in lower urinary tract symptoms
研究概览
简要总结
This study named a comparative clinical study to evaluate the efficacy of Ksharapippali and Mahodarahara kashaya in Vatashteela with special reference to Benign Prostatic Hyperplasia that will be conducted in Government Ayurvedic Medical College and Hospital Bengaluru Karnataka.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Subject with signs and symptoms of Vatashteela (BPH).
- •2.Subject with mild to moderate BPH with score 1-19, as per The International Prostate Symptom Score index.
排除标准
- •1.Subject with malignancy.
- •2.Subject more than 80 years of age.
- •3.Subject with severe cardio vascular, Renal or Hepatic disorders, uncontrolled Hypertension & Diabetes mellitus.
- •4.Subjects with immune compromised diseases.
- •5.Subject with USG findings suggestive of severe Hydroureteronephrosis.
- •6.Post-void Residual urine volume more than 100ml as assessed by USG of Abdomen and pelvis.
结局指标
主要结局
Reduction in lower urinary tract symptoms
时间窗: 28 days
次要结局
- Decrease in post void residual urine volume & reduction in enlargement of prostate(28 days)
研究者
研究点 (1)
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