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临床试验/CTRI/2025/05/086366
CTRI/2025/05/086366招募中2/3 期

A Clinico Comparative Study Of Shwadamstradi Taila Uttarbasti With And Without Matrabasti In The Management Of Mutrakruccha With Special Reference To Urethral Stricture An Open Label Randomized Comparative Clinical Trial

Government Akhandanand Ayurved College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Improvement in patients signs and symptoms like reduced Frequency of micturition and Reduced pain while micturition

研究概览

简要总结

Stricture urethra though a rare condition still is a rational and troublesome problem in the international society. There is marked increase in incidence starting at the age of 55 years. Studies have suggested that men appear to be at more risk than that of females as they have longer urethra. Worldwide it is estimated that male urethral strictures have a prevalence of The etiology of urethral strictures is divided into 4 major groups Idiopathic Iatrogenic inflammatory and Post traumatic. Urethral stricture may present in the of range of manifestations from an asymptomatic presentation to severe discomfort secondary to urinary retention .It is common condition resulting in many office appointments emergency room visits and hospital admissions with the estimated rate around 1 to 9 strictures per 1000 people in India.

Stricture usually arising from prolonged catheterization radiation BPH prostatic and trans urethral surgery repeated UTI and STD.  Approximately 30 percent of urethral strictures are idiopathic and most common causes of urethral stricture today are traumatic or iatrogenic. Iatrogenic urethral trauma usually results from improper or prolonged catheterization and accounts for 32 percent of strictures. Some patients may choose to manage their stricture disease with periodic urethral dilations. The goal is to stretch the scar without producing additional scarring. It may be curative in patients with isolated epithelial strictures means no involvement of corpus spongiosum. Most of the time urethral stricture is seen in elderly population with a marked increase after 55years of age. Urethral stricture disease is still a prevalent problem with an estimated incidence of 0.6 percent in susceptible population. In patients with urethral stricture disease older than 60 years 6.5percent  underwent retrograde urethrography RUG studies. Urethral dilation remains a very common outpatient procedure among Medicare beneficiaries. Patients with urethral stricture are considered a vulnerable population as they experienced high rates of UTIs and incontinence  as sequelae of the disease. In modern surgery effective therapy has been establish for the condition but more recurrences and complications. The discussion on surgical techniques and diagnostic methods of one of the oldest pathologies known to the urologist is still continuous. Thus  the urethral stricture remains a challenging pathology today. Hence there is need to find other treatment option for Urethral stricture. Acharya sushruta mentioned Ghrita and Taila Uttarbasti in management of the Urethral stricture.  In Uttarbasti Drug reduce the fibrosis in stricture part of urethra. Matrabasti Drug pacifies the pain particularly at the perineal region as the Mutravaha Srotasa become free from vitiated Vata. By keeping mentioned things at point of convergence shwadamstradi taila Uttarbasti with and without Matrabasti is selected for the management of Mutrakruccha with special reference to urethral stricture. Though there are multi folded treatment modalities exists in western medical science they are having own advantages and disadvantages so there was an intense and persistant scope to find out simple and easily available treatments for relieving painful micturition by increasing constricted urethral lumen diameter without any adverse effect. Uttarabasti a para surgical procedure is the most effective available treatment in Ayurveda for the diseases of Mutravaha Strotas. In Mutrakruccha there is vitiation of Vata especially Apan vayu which is located at Shroni Basti  Medhra leads to obstruction of urine outflow due to this Vimargagamana and Marga Avrodhan occurs. Therefore

main principle should be to Vatanuloman and Mutrashodhan to return the normal qualities of Apan Vayu. Medicated oil prepared out of Gokshur swarasa Gud Kshir Shunthi which are prepared by Tailapak method.Due to this Sanga gets removed from Mutravaha Strotasa particularly at the urethra leading to increase in size of the lumen which was constricted previously diameter at the site of stricture. As the Mutravaha Strots become free from the vitiated Vata. considering all the views Shwadamstradi taila

Uttarbasti with and without Matrabasti has been selected for the management of Mutrakruccha with special reference  to Urethral Stricture.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Patient selected irrespective of their Religion, Cast, Gender without any bars Age between 18 to 60 years Controlled case of Diabetes with HbA1C less than 7 percentage and Hypertension with BP less than 150 systolic and 90 diastolic Patient having sign &symptoms of Mutrakruccha Urethral Stricture fulfilling diagnostic criteria will be included.

排除标准

  • Patient below the age of 18 years or above the age of 60 years Patient have impacted calculus in the urethra and urinary bladder neck Benign Prostatic Hyperplasia Nephrotic syndrome and Neoplasm of lower urinary tract UTIs Atonic Bladder Patient with systemic disease like Asthma Epilepsy Autoimmune disorders Multiple Sclerosi Heart Disease Uncontrolled case of Diabetes with HbA1C more than 7percentage and Hypertension with BP more than 150 systolic and 90 Diastolic Patient with HIV HBsAg STDs Patient with malignancy will be excluded.

结局指标

主要结局

Improvement in patients signs and symptoms like reduced Frequency of micturition and Reduced pain while micturition

时间窗: 21 days

次要结局

  • which procedure is more helpful in relieving the symptoms of mutrakruccha(2 months)

研究者

发起方
Government Akhandanand Ayurved College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Pranit R Nachan

Government Akhandanand Ayurved College Ahmedabad

研究点 (1)

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