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
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)
