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A study to assess the efficacy of Shweta parpati in uncomplicated lower urinary tract infections

Recruiting
Conditions
Urinary tract infection, site notspecified,
Registration Number
CTRI/2019/03/018313
Lead Sponsor
Mandsaur Institute of Ayurved Education and Research Mandsaur
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
90
Inclusion Criteria

Patient Diagnosed with UTI as per ICD10 N39 Diagnostic Criteria.

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Burning sensation during urination15th day
Urinary urgency and frequency15th day
Cloudy urine15th day
In Urine routine examination absence of bacteria15th day
Absence of the symptoms mentioned in 2017 ICD-10-CM Diagnosis Code N39 for UTI15th day
Lower abdominal discomfort15th day
Subjective data (self-made symptom scoring) 0 Nill15th day
Secondary Outcome Measures
NameTimeMethod
NANA

Trial Locations

Locations (1)

susrutha institute of ayurvedic science research and panchakarma hospital

🇮🇳

Thiruvananthapuram, KERALA, India

susrutha institute of ayurvedic science research and panchakarma hospital
🇮🇳Thiruvananthapuram, KERALA, India
Dr Krishnakumar k
Principal investigator
09446583803
drkrishnakumarmd@gmail.com

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