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
|
|
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
|
|
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
|
|
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. |