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临床试验/CTRI/2024/05/066978
CTRI/2024/05/066978尚未招募2/3 期

A Comparative Clinical Study To Evaluate The Efficacy Of Dashmooladi Kwath And Kalyanaka Kshara With Dashmooladi Kwath After Yog Basti In The Managment Of Vatashtheela (Benign Prostatic Hyperplasia)

All India Institute Of AyurvedaNew Delhi1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Improvement In Incomplete Emptying,Frequency,Intermittency,Urgency,Weak Stream,Straining,Nocturia In Patients Of Vatashtheela (BPH).

研究概览

简要总结

A. Primary Objectives

To evaluate the efficacy of Dadhmooladi Kwath and Kalyanaka Kshara with Dashmooladi kwath after Yog Basti in the management of Vatashtheela (BPH) in patients having age between 40 to 70 years by estimating the level of IPSS-International Prostate Symptom Score (created by American Urology Association).

B. Secondary Objectives

·       To determine the improvement in IPSS-International Prostate Symptom Score (AUA) in patients of Vatashtheela (BPH).

·       To evaluate reduction in Prostate Size.

·       To evaluate reduction in Prostate weight.

·       To validate a Module designed for management of Vatashtheela (BPH).

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
Male

入选标准

  • 1 Male Patients Having Age Between 40 TO 70 Years.
  • 2 Patients Having Signs And Symptoms Of Vatashtheela(Bph).
  • 3 Patients Diagnosed With Grade 1 2 Or
  • 4 Patients Having Psa Less Than Or Equal To 4.

排除标准

  • 1 Patients Having Age Below 40 And Above
  • 2 Patients Diagnosed With Bph Grade
  • 3 Patients Having Psa Greater Than
  • 4 Patients With Malignancies And Congetinal Deformities Of Urogenital Tract.
  • 5 Patients With Umcontrolled Diabetes And Hypertension.
  • 6 Patients Unfit For Niruha And Anuvasana Basti.

结局指标

主要结局

Improvement In Incomplete Emptying,Frequency,Intermittency,Urgency,Weak Stream,Straining,Nocturia In Patients Of Vatashtheela (BPH).

时间窗: Day 0,1 Week And 6 Weeks

次要结局

  • 1.Improvement In Quality Of Life Assesed With The Help Of International Prostate Symptom Score.(2.Changes In Post Voidal Residual Volume Of Urine And Prostate Size On Ultrasound.)

研究者

发起方
All India Institute Of AyurvedaNew Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr.Rupesh Gangurde

All India Institute Of Ayurveda,New Delhi

研究点 (1)

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