| 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
|
|
|
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
|
|
|
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
|
|
|
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 | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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 |