跳至主要内容
临床试验/CTRI/2025/02/080616
CTRI/2025/02/080616
尚未招募
不适用

A Randomised Controlled Clinical Trial to Assess The Efficacy of Haritakyadi Kwath and Yavakshar in Management of Vatastheela W.S.R to Benign Prostatic Hyperplasia

Dr VJD Gramin Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr VJD Gramin Ayurved Mahavidyalaya
入组人数
60
试验地点
1
主要终点
Subjective criteria

概览

简要总结

Benign Prostatic Hyperplasia (BPH), is a common condition

among aging males, characterized by prostate gland enlargement

leading to lower urinary tract symptoms. It expresses both the

obstruction and the irritability of the urinary system.

Vatashtheela is a hard, elevated, mobile swelling. It is one of the

thirteen types of Mootraghata. Vatashtheela reflects the symptomsimilar to the Lower Urinary Tract Symptoms (LUTS) and may be

corelated with Benign Prostatic Hyperplasia (BPH). Vatashtheela  is a condition of obstructive uropathy which may present with either partial or complete retention of urine.

The prevalence of Benign Prostatic Hyperplasia increases

after the age of 40 years, autopsy studies have observed a  histological prevalence of 8%, 50%, and 80% in the 4th, 6th and 9th decade    of life, respectively. Since Benign Prostatic Hyperplasia is not a  rapid progressive disease so the management of Benign Prostatic

Hyperplasia can be achieved by adapting conservative measure  and lastly surgical intervention as it may lead to many  complications  like postoperative morbidity, impotence, retrograde ejaculation etc.  Apart from that a cumulative probability for reoperation has been  estimated up to 15% of operated cases within 8-10 years.  Although administration of conservative modern treatment  i.e. hormone therapy has good advantages but has side effects like loss          of  libido, Impotence, gynecomastia etc.

Hence, Ayurveda may be more effective as well as safe

for conservative management of B.P.H.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Patients presenting with classical signs and symptoms of Benign Prostatic Hyperplasia.

排除标准

  • CA Prostate Urethral stricture Benign tumor of urethra Malignant tumor of urethra Urethral injury Urethral calculi Age above 80 years and below 40 years Patients with systemic diseases like uncontrolled Hypertension (more than 150/90 mm Hg) and uncontrolled Diabetes mellitus (RBS more than 180 mg/dl), Tuberculosis, STD, HIV, HBSAg.

结局指标

主要结局

Subjective criteria

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

Quality of life due to urinary symptoms

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

International prostate symptoms score IPSS

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

Objective criteria

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

Prostate size (volume) by USG

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

Residual urine volume by USG

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

Urine flow rate

时间窗: Before treatment and after treatment and follow up at 15 and 30 days

次要结局

  • Decrease in symptoms of Vatastheela and Quality of life due to urinary symptoms(18 months)

研究者

发起方
Dr VJD Gramin Ayurved Mahavidyalaya
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Khushal Chouhan

Dr VJD Gramin Ayurved Mahavidyalaya

研究点 (1)

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