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CTRI Number  CTRI/2021/07/035084 [Registered on: 23/07/2021] Trial Registered Prospectively
Last Modified On: 23/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical and therapeutic evaluation of haritakyadi kwath on mutrakriccha w.s.r. to E- coli. 
Scientific Title of Study   A clinical and therapeutic evaluation of haritakyadi kwath on mutrakriccha w.s.r. to E- coli. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nisha yadav 
Designation  M D Scholar of rog nidan 
Affiliation  Madan Mohan Malviya Government Ayurveda college Udaipur  
Address  Madan Mohan Malviya government Ayurveda college Udaipur amba mata 313004

Udaipur
RAJASTHAN
313004
India 
Phone  7568384921  
Fax    
Email  yadavnishasingh06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof pankaj marolia 
Designation  Professor and Head of department 
Affiliation  Madan mohan Malviya government ayurveda college Udaipur 313004 
Address  PG department of rog nidan madan mohan malviya government Ayurveda Udaipur ambha mata 313004

Udaipur
RAJASTHAN
313004
India 
Phone  9413193101  
Fax    
Email  Pankajmarolia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nisha yadav 
Designation  MD scholar of rog nidan 
Affiliation  Madan mohan malviya government ayurveda College Udaipur 313004 
Address  PG department of rog nidan madan mohan malviya government Ayurveda college Udaipur 313004

Udaipur
RAJASTHAN
313004
India 
Phone  7568384921  
Fax    
Email  yadavnishasingh06@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya government Ayurveda college Udaipur  
 
Primary Sponsor  
Name  Madan Mohan Malviya government Ayurveda college  
Address  Madan Mohan Malviya government Ayurveda college Udaipur - Ambamata 313004 Rajasthan  
Type of Sponsor  Government 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 Nisha yadav  Madan mohan malviya government ayurveda college udaipur   rog nidan department
Udaipur
RAJASTHAN 		 7568384921

yadavnishasingh06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Magan Mohan Malviya government Ayurveda college Udaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere. Ayurveda Condition: MUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Haritakyadi kwath  30ml twice a day orally after meal for 60 days 
Comparator Agent  Nill  Nill 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. patient willing to give consent for clinical trial.
2. Patient having any clinical signs and symptoms of mutrakriccha(UTI)
3. Patient with positive urine culture. 
 
ExclusionCriteria 
Details  1. Patient with upper urinary tract infection.
2. Pregnant women
3. patient with hematuria, renal failure, nephrotic syndrome. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in sign and symptoms of mutrakriccha.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in mutrakriccha(UTI) grading score.  60 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nill 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
INTRODUCTION

     The lakshan of mutrakrichra are also similar to the symptoms of urinary tract infection . the chikitsa and oushadha yogas mentioned by Acharya’s are having antibacterial and diuretic properties.

     Urinary tract infections are second most widespread type of infectivity in the body secretarial for about 8.1 million visits to health concern provider every year. UTI commonly encounters with Escherichia coli accounts for about 85% of community acquired.

     Over 50% of all women will experience at least one UTI during their lifetime, with 20 to 30 percent experiencing recurrent UTIs.

NEED FOR STUDY
    At present there are many antibiotics used to solve the problem of UTI but they are not able to reach the proper target due to the limitation of antibiotics and drug resistance of microorganisms to the antibiotics, they affects several related metabolic systems of the body including the immune system and make
the body more susceptible to future attacks.so this clinical study has been carried out to establish the efficacy and sensitivity of the  haritakyadi kwath on e.coli infection of urinary tract.
STUDY DRUG
Haritakyadi kwath (chakradatta 31/7)


 
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