跳至主要内容
临床试验/CTRI/2019/03/018313
CTRI/2019/03/018313招募中不适用

A case controlled clinical study to evaluate the efficacy of Shwetaparpati in Uncomplicated Lower urinary tract infections WSR to Mootrakruchra’

Mandsaur Institute of Ayurved Education and Research Mandsaur1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年4月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Burning sensation during urination

研究概览

简要总结

Urinary tract infection (UTI) isthe most common bacterial infection managed in general medical practice andaccounts for 1–3% of consultations. Prevalence in women is 3% at age 20, risingby 1% per decade thereafter. The term UTI covers a range of conditions ofvarying severity from simple urethritis and cystitis to acute pyelonephritiswith septicaemia Lower urinary tract symptoms resembles mootra kruchra adisease mentioned in Ayurveda.

In Modern medicine Antibioticshave been used for urinary tract infections. Antibiotics have their ownlimitations like development of resistance to the microorganisms, reinfectionand relapses etc. Antimicrobial resistance adversely affects the outcome ofcommunity- and hospital-acquired infections

There are several researcheswhich is done to find out a solution for Lower UTI through and Ayurvedicmanagement, but they are with improper data and methodology some of them, arewith  inadequate samples and study designeven though they are explaining about promising and fascinating results. Onlyvery few articles are seen in pear reviewed journals. But the success inmanagement of UTI is the every days routine clinical practice of Ayurveda. The excellentresults were masked due to lack of awareness or resources of the physicians to reportit or publish it so these results were not rigorously evaluated in researchsettings. The usage of Swetaparpati is also claims by the physicians as it isone among the wonder drug of Ayurveda which can make changes in the urine andcan destroy the infection .

In order to generate preliminaryevidence about the efficacy of shwetha parpati in the management ofuncomplicated lower urinary tract infections, a pre and post test  case control  study is proposed. Ninety eligible studysubjects meeting inclusion criteria with baseline bacteriuria , andidentification of the pathogen  diagnosedthrough culture and sensitivity  the first group is trial group whichconsist of sample size n=60 will be administered 14 days of swethaparpaticapsules (350 mg ) Tid with cold water  will be performed and the treatment will beconcluded with post test assessment on the 15th day .there will be two followups on 21st day and on 28th day. The second group which is a control group  of sample size of n=30  will be served existing standard of care as per the culture result with the help of an expertmodern  doctor in the nearby vicinity

Study subjects will be assessed before and after treatment for improvementusing presence of bacteria in the urine sample  , comparison and analysis will be done byusing paired t test.

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patient Diagnosed with UTI as per ICD10 N39 Diagnostic Criteria.

排除标准

  • Nephrolithiasis Candidiasis of urinary tract Pregnancy Renal failure Liver failure Foreign body in the urinary tract Instrumentation of urinary tract Pyelonephritis Hydronephrosis.

结局指标

主要结局

Burning sensation during urination

时间窗: 15th day

Urinary urgency and frequency

时间窗: 15th day

Cloudy urine

时间窗: 15th day

In Urine routine examination absence of bacteria

时间窗: 15th day

Absence of the symptoms mentioned in 2017 ICD-10-CM Diagnosis Code N39 for UTI

时间窗: 15th day

Lower abdominal discomfort

时间窗: 15th day

Subjective data (self-made symptom scoring) 0 Nill

时间窗: 15th day

次要结局

  • NA(NA)

研究者

发起方
Mandsaur Institute of Ayurved Education and Research Mandsaur
申办方类型
Private medical college

研究点 (1)

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