| CTRI Number |
CTRI/2025/02/080170 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To search for microscopic infection causing bacteria in urine and relate it with mutrakrucchra- An Ayurveda terminology related to urine infection |
|
Scientific Title of Study
|
Identification and categorization of pathogens in doshaja mutrakrucchra vis-a-vis urinary tract infections |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sannuthi Chandana Sri |
| Designation |
PG Scholar |
| Affiliation |
Jss Ayurveda Medical College |
| Address |
Jss Ayurveda Medical College
41/E Lalithadripura road
Myusuru
Mysore
KARNATAKA
570028
India |
| Phone |
9502030912 |
| Fax |
|
| Email |
chandanasannuthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan B G |
| Designation |
Associate professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
JSS Ayurveda Medical College
41/E Lalithadripura road
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9986284748 |
| Fax |
|
| Email |
drmadhusudanbg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sannuthi Chandana Sri |
| Designation |
PG Scholar |
| Affiliation |
Jss Ayurveda Medical College |
| Address |
Jss Ayurveda Medical College
41/E Lalithadripura road
Myusuru
Mysore
KARNATAKA
570028
India |
| Phone |
9502030912 |
| Fax |
|
| Email |
chandanasannuthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical Hospital
Lalithadripura road
Mysuru-570028
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Sannuthi Chandana Sri |
| Address |
JSS AYURVEDA MEDICAL COLLEGE
41/E lalithadripura road
Mysuru, karnataka 570028 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sannuthi Chandana Sri |
Jss Ayurveda Medical Hospital |
Dept of Roga Nidan evam Vikriti Vigyan
41/E Lalithadripura road
Mysuru 570028
Mysore
KARNATAKA |
9502030912
chandanasannuthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee - Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to participate in this study
Subjects fulfilling diagnostic criteria
Subjects of both the genders of all age groups |
|
| ExclusionCriteria |
| Details |
Subjects with Sannipataja,Sharkaraja,Ashmarija,Shukraja,Kshataja, Shakrut Mutrakrucchra
Subjects with positive HIV,HbsAg
Sample of catheter associated urinary tract infections |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Classification of Doshaja Mutrakrucchra based on causative organism |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mutrakrucchra is a disease characterized by difficulty in voiding of urine. This is classified into 8 types – Vataja, Pittaja, Kaphaja, Sannipataja, Ashmarija, Kshataja, Shukraja and Sharkaraja. The clinical features are similar to that of urinary tract infections caused by microbes. UTI is commonly caused by Escherichia coli, Staphylococcus saprophyticus, Staphylococcus aureus, Enterococcus species, Klebsiella pneumoniae, Citrobacter species, Proteus species, Acinetobacter, Morganella species, Pseudomonas aeruginosa and Yeast The prevalence of UTI in women is greater than men. In women 3% of prevalence and increasing by about 1% in each subsequent decade. Whereas after the age of 50 years, UTI occurrence is also more in male and also in the age group <1year . There is no direct reference mentioned in Samhita that Mutrakrucchra is caused by Krimi. Whereas, based on the similarity in the clinical features, we can understand that UTI is similar to that of Mutrakrucchra. Therefore, we can infer that Mutrakrucchra can be caused due to Krimi also. The causative organisms of the UTI are the inhabitants of colon and blood 9, from this we can infer that if Purishaja Krimi or Raktaja Krimi enters Mutravaha Srotas, it causes Mutrakrucchra. Hence, this study intends to identify the microorganisms responsible for causation of Mutrakrucchra and categorize them among Doshaja Mutrakrucchra. Thus, this will be a first of its kind study to bridge the Ayurveda classical knowledge to modern microbiology understanding to characterize microorganisms causing different types of Mutrakrucchra, which can be a torch bearer for future clinical approach in cases of Mutrakrucchra. |