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临床试验/CTRI/2022/07/044050
CTRI/2022/07/044050尚未招募不适用

An Open Non Randomized Single Arm, Single Centric Clinical Trial To Determine The Effectiveness Of Venkara Parpam In The Management Of Neerkattu Vatham (Benign Prostatic Hyperplasia) Among Out Patients Attending Ayothidoss Pandithar Hospital, National Institute Of Siddha

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年7月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Assessment by clinical symptoms using

研究概览

简要总结

Introduction

This is an open non randomized single arm, single centric clinical trial to

evaluate the effectiveness of venkara parpam in the management of neerkattu vatham (benign

prostatic hyperplasia) patients through International prostate symptom

score(IPSS),Prostate specific antigen(PSA) and Ulterasound sonography(USG) before

andafter treatment. Benign Prostatic Hyperplasia is a pathologic process that contributes

to the development of lower urinary tract symptoms in men. Such symptoms, arising from

lower urinary tract dysfunction, are further subdivided into voiding symptoms and

storage symptoms. BPH is one of the common diseases of the male community.

summarizing data from five prior studies showed that no men younger than 30 had

evidence of BPH. The prevalence of BPH accounts nearly 8% of men aged between 45

to 50 years, around 50% affected men aged those were between 50-80 years and in men

above 80 years of age the prevalence rate is almost 80%. An estimated 50% of men

demonstrate histopathologic BPH changes by age 60 years.. So my aim is to treat the

Neerkattu vatham(Benign Prostatic Hyperplasia) with the Siddha classical drug

VENKARA PARPAM.

MATERIALS AND METHODS:

A Total of 25 diagnosed patients of Neerkattu vatham(Benign Prostatic Hyperplasia)

within the age limit of 50 - 80 years willing to participate in the study ,by signing the

consent form will be enrolled in the study. CA Prostate,urinary bladder calculus,acute and

chronic renal failure,diabetic nephropathy,stricture urethra will be excluded. Assessment

in improvement is done through International prostate symptom score(IPSS),Prostate

specific antigen(PSA) and Ulterasound sonography(USG) before and after treatment.

RESULTS AND DISCUSSION:

The result will be statistically analyzed

KEYWORDS: Neerkattu vatham,Benign Prostatic Hyperplasia,Venkara Parpam

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
50.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Patients having symptoms such as delay in initiating micturition,hesitancy,weak urinary stream,straining to void,sensation of incomplete emptying and terminal dribbling.
  • Increased residual urine volume
  • Nocturia ,urgency,bladder pain, dysuria
  • PSA (Prostate specific antigen) less than 10ng/ml.
  • USG prostate volume not more than 80 cc.

排除标准

  • KNOWN CASE OF CA prostate Urinary bladder calculus Acute and chronic renal failure Diabetic nephropathy Stricture urethra PSA more than 10 ng/ml USG prostate volume more than 80ml.

结局指标

主要结局

Assessment by clinical symptoms using

时间窗: Screening - 2 months | Enrolment - 2 months | Drug - 4 months | Data analysis - 2 months | Follow up - 2 months

IPSS assessing scale.

时间窗: Screening - 2 months | Enrolment - 2 months | Drug - 4 months | Data analysis - 2 months | Follow up - 2 months

次要结局

  • 1. To assess the changes in PSA Level(2. To assess the reduction in size of the prostrate gland and prostrate volume and)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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