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CTRI Number  CTRI/2024/12/078817 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Urinary Tract Infections by Ayurveda  
Scientific Title of Study   Evaluation of antibacterial activity of some Ayurvedic medicinal plants-based drug w.s.r to Urinary tract infections (UTIs) 
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 Kanhaiyalal Sharma 
Designation  Professor & Head Department of Dravyaguna 
Affiliation  Govt Autonomous Ayurved college and Hospital Gwalior 
Address  Govt. Autonomous Ayurved college and Hospital Gwalior
Amkho Lashkar Gwalior
Gwalior
MADHYA PRADESH
474001
India 
Phone  9893734364  
Fax    
Email  klhepa6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul Gupta 
Designation  Assistant Professor Department of Dravyyaguna 
Affiliation  Govt Autonomous Ayurved college and Hospital Gwalior 
Address  Govt Autonomous Ayurved college and Hospital Gwalior
Amkho Lashkar Gwalior
Gwalior
MADHYA PRADESH
474001
India 
Phone  9926252001  
Fax    
Email  drrahul786@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul Gupta 
Designation  Assistant Professor Dept of dravyaguna 
Affiliation  Govt. Autonomous Ayurved college and Hospital Gwalior 
Address  Govt. Autonomous Ayurved college and Hospital Gwalior
Amkho Lashkar Gwalior
Gwalior
MADHYA PRADESH
474001
India 
Phone  9926252001  
Fax    
Email  drrahul786@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Maharashi Patanjali Sanskrit Sansthan Bhopal 
Address  Sanskrit Bhavan Tulsi Nagar Bhopal Pincode 462003 
Type of Sponsor  Other [research project] 
 
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 Rahul Gupta  Government Autonomous Ayurved College and Hospital Gwalior  Room No 12 Research OPD Groud Floor Government Autonomous Ayurved College and Hospital Amkho Lashkar Gwalior 474001
Gwalior
MADHYA PRADESH 
9926252001

drrahul786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
office of the Govt. Autonomous ayurved college and hospital Gwalior Institutional Ethical Clearance committee  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. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ayurved plant Based Medicine , Reference: classical, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: patient will be advised with recommended Diet during course of intervention
2Comparator ArmDrugClassical(1) Medicine Name: Ayurved plant Based Medicine, Reference: classical, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Uncomplicated UTI 
 
ExclusionCriteria 
Details  complicated UTI
other disease with urinary tract
infection by pathogens other than bacteria
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Recovery of urinary tract infection   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
complete Recovery of urinary tract infection  8 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   08/01/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Uncomplicated Lower urinary tract infection is the most common infections which are faced by human beings in this era. Recent reports show that UTI is more affecting the women in the age group of 15-44 than men. E.coli causes 80 % of uncomplicated UTI. Most of the studies done in high- or middle-income countries revealed that other pathogens (secondary pathogens) such as Klebsiella species, Enterobacter, Proteus species usually found in study participants with complicated UTI. All these symptoms of the disease closely resemble one among the diseases mentioned in Ayurveda under Mutravaha-srotho-dushti-vikaranamedMutrakruchra. Mutravaha-srotas is closely involved with Bastimarma, as it is one among the critical Trimarma where the Prana is said to be having its Ashrayasthana So, the management of this disorder has higher therapeutic value.  In Modern medicine, Antibiotics used for urinary tract infections. Antibiotics have their limitations like the development of resistance to the microorganisms, reinfection and relapses. Antimicrobial resistance adversely affects the outcome of community- and hospital-acquired infections in developing countries. So, to solve this problem, it is highly relevant to search for an alternative treatment which is both effective and economical. therefore we have selected present study and Ayurvedic plant-based drug which are effective in in vitro antibacterial activity study as well as safe in in vivo animal experiments, those Ayurvedic plant-based drug will be jointly used to evaluate the role of Ayurved medicines in the management of  urinary tract infection 

 
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