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CTRI Number  CTRI/2019/03/018313 [Registered on: 29/03/2019] Trial Registered Prospectively
Last Modified On: 02/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to assess the efficacy of Shweta parpati in uncomplicated lower urinary tract infections 
Scientific Title of Study   A case controlled clinical study to evaluate the efficacy of Shwetaparpati in Uncomplicated Lower urinary tract infections WSR to Mootrakruchra’ 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishnakumar K 
Designation  PhD Ayurveda scholar  
Affiliation  Mandsaur Institute of Ayurved Education &Research/Mandasour University  
Address  Mandsaur Institute of Ayurved Education and Research Mandsaur
Jyothjrmadam Mulayancode Kattakada PO thiruvananthapuram Kerala 695572
Mandsaur
MADHYA PRADESH
458001
India 
Phone  919446583803  
Fax    
Email  drkrishnakumarmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RATNAPRAVA MISRA MD AYU PHD 
Designation  Professor and HOD 
Affiliation  Mandsaur Institute of Ayurved Education &Research/Mandasour University  
Address  Department of Kayachikitsa Mandsaur Institute of Ayurved Education and Research Mandsaur

Mandsaur
MADHYA PRADESH
458001
India 
Phone  918281931485  
Fax    
Email  dr.rpmishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR RATNAPRAVA MISRA MD AYU PHD 
Designation  Professor and HOD 
Affiliation  Mandsaur Institute of Ayurved Education &Research/Mandasour University  
Address  Department of Kayachikitsa Mandsaur Institute of Ayurved Education and Research Mandsaur

Mandsaur
MADHYA PRADESH
458001
India 
Phone  918281931485  
Fax    
Email  dr.rpmishra@gmail.com  
 
Source of Monetary or Material Support  
krishnakumar primary investigator, PhD scholar ,Mandasour Institute of Ayurvedic education and Research , Mhow- Neemuch Road, B R Nahata Marg, Opp. to Krishi Upaj Mandi, Mandsaur, Madhya Pradesh – 458001 
Mandasour Institute of Ayurvedic education and Research Mandasour University  
susrutha institute of ayurvedic sciences and panchakarma hospital kattakada , thiruvananthapuram,kerala 
 
Primary Sponsor  
Name  Mandsaur Institute of Ayurved Education and Research Mandsaur 
Address  Mandsaur Institute of Ayurved Education and Research Mandsaurdistrict madhyapadesh-458001  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishnakumar k   susrutha institute of ayurvedic science research and panchakarma hospital   Kattakada ,Kattakada P.O , pin number 695572
Thiruvananthapuram
KERALA 
09446583803

drkrishnakumarmd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee Mandasour institute of Ayurvedic education and Research mandasour university   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A case controlled clinical study to evaluate the efficacy of Shwetaparpati in Uncomplicated Lower urinary tract infections WSR to Mootrakruchra’  the patients of uncomplicated lower urinery tract infection will be administered 14 days of swethaparpati capsules (350 mg ) Tid with cold water will be performed and the treatment will be concluded with post test assessment on the 15th day .there will be two follow ups on 21st day and on 28th day 
Comparator Agent  the controle group is the existing standard of care used in modern medicine   after seing the culture and sensitivity report one expert modern medicine doctor will deside which medicine to be used as per standard of care  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient Diagnosed with UTI as per ICD10 N39 Diagnostic Criteria 
 
ExclusionCriteria 
Details  Nephrolithiasis
Candidiasis of urinary tract
Pregnancy
Renal failure
Liver failure
Foreign body in the urinary tract
Instrumentation of urinary tract
Pyelonephritis
Hydronephrosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In Urine routine examination absence of bacteria
Subjective data (self-made symptom scoring) 0 Nill
Absence of the symptoms mentioned in 2017 ICD-10-CM Diagnosis Code N39 for UTI
Urinary urgency and frequency
Burning sensation during urination
Lower abdominal discomfort
Cloudy urine
 
15th day 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Urinary tract infection (UTI) is the most common bacterial infection managed in general medical practice and accounts for 1–3% of consultations. Prevalence in women is 3% at age 20, rising by 1% per decade thereafter. The term UTI covers a range of conditions of varying severity from simple urethritis and cystitis to acute pyelonephritis with septicaemia Lower urinary tract symptoms resembles mootra kruchra a disease mentioned in Ayurveda.

In Modern medicine Antibiotics have been used for urinary tract infections. Antibiotics have their own limitations like development of resistance to the microorganisms, reinfection and relapses etc. Antimicrobial resistance adversely affects the outcome of community- and hospital-acquired infections

There are several researches which is done to find out a solution for Lower UTI through and Ayurvedic management, but they are with improper data and methodology some of them, are with  inadequate samples and study design even though they are explaining about promising and fascinating results. Only very few articles are seen in pear reviewed journals. But the success in management of UTI is the every days routine clinical practice of Ayurveda. The excellent results were masked due to lack of awareness or resources of the physicians to report it or publish it so these results were not rigorously evaluated in research settings. The usage of Swetaparpati is also claims by the physicians as it is one among the wonder drug of Ayurveda which can make changes in the urine and can destroy the infection .

In order to generate preliminary evidence about the efficacy of shwetha parpati in the management of uncomplicated lower urinary tract infections, a pre and post test  case control  study is proposed. Ninety eligible study subjects meeting inclusion criteria with baseline bacteriuria , and identification of the pathogen  diagnosed through culture and sensitivity  the first group is trial group which consist of sample size n=60 will be administered 14 days of swethaparpati capsules (350 mg ) Tid with cold water  will be performed and the treatment will be concluded with post test assessment on the 15th day .there will be two follow ups 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 expert modern  doctor in the nearby vicinity  

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

 
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