CTRI/2020/11/029083尚未招募2 期
"RANDOMIZED CONTROLLED CLINICAL TRIAL OF EFFICACY OF PASHANBHEDADI GHANVATI IN THE MANAGEMENT OF VAATASHTHILA W.S.R. TO BENIGN PROSTATE HYPERPLASIA"
Preeti Bhalke1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年1月12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
- 36
- 试验地点
- 1
- 主要终点
- To find out how Pashanbhedadi Ghanvati reduces the prostate size and post void residual volume
研究概览
简要总结
"This Study Is Randomized Open Labelled Controlled Clinical Trial Of Efficacy Of Pashanbhedadi Ghanvati In The Management Of Vaatashthila With Special Reference To Benign Prostate Hyperplasia For 45 days And Follow Up And Assesment on 15th, 30th, 45th Day. This study is conducted as a compulsary part of PG course at single centre. The primary outcome is to find out Pashanbhedadi Ghanvati reduces the size of prostate and post void residual volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients having prostate size 30 to 100 gram Patients having post void residual volume 50 to 200 ml Patients willing to participate in study Patients having mild 1 to 7 moderate 8 to 19 international prostate symptom score Patients with severe 20 to 35 international prostate symptom score with no other consequences of benign prostate Hyperplasia and reluctant for surgery.
排除标准
- •Patients of malignant prostatic enlargement or prostatitis or uremia septicemia or renal failure Patients having other urological pathologies like nephrotic syndrome or glomerulo nephritis or chronic kidney diseases etc Increased serum creatinine and blood urea Patients having HIV or HBsAg or major systemic disorders like uncontrolled HTN or DM or PTB etc Patients participating in other clinical trials Patients having hematuria Patients with acute urine retention which needs surgical intervention Patients currently using any other form of medicle therapy for benign prostate hyperplasia.
结局指标
主要结局
To find out how Pashanbhedadi Ghanvati reduces the prostate size and post void residual volume
时间窗: 45 days
次要结局
- To establish the better medicinal alternative in the management of Vaatashthila(To find out effects of Pashanbhedadi Ghanvati on the other symptoms of Vaatashthila)
研究者
研究点 (1)
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