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CTRI Number  CTRI/2022/05/042442 [Registered on: 10/05/2022] Trial Registered Prospectively
Last Modified On: 09/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study conducted to see the effect of Yavakshara in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection. 
Scientific Title of Study   A Randomized Standard Control Clinical Study to evaluate the effect of Yavakshara in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satender 
Designation  MS Scholar Shalyatantra 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnatka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus

Bagalkot
KARNATAKA
587101
India 
Phone  9991919978  
Fax    
Email  drsatenderchauhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pallavi A Hegde 
Designation  Professor 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnatka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus

Bagalkot
KARNATAKA
587101
India 
Phone  9448636321  
Fax    
Email  drpallaviah@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M M Salimath 
Designation  Principal and Professor 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnatka 
Address  Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka - 587101 
 
Primary Sponsor  
Name  BVVS Ayurved Medical College and Hospital 
Address  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot, Karnatka - 587101 
Type of Sponsor  Private 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 Satender  BVVS Ayurved Medical College and Hospital  OPD and IPD Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital
Bagalkot
KARNATAKA 		 9991919978

drsatenderchauhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka  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: PITTAJAMUTRAKRUCCRAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yavakshara, Reference: Bhaishajya Ratnavali Chapter - Mutrakricchra 34/15, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Chandraprabha Vati, Reference: Bhaishajya Ratnavali Chapter - Prameha Adhyaya 37/102-110, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with classical Lakshana of Pittaja Mutrakrichra (L.U.T.I)
Patients aged between 20 to 60 years.
 
 
ExclusionCriteria 
Details  Patients suffering with any systemic disorders like tuberculosis, diabetes mellitus etc.
Patient suffering from urinary calculi.
Patient suffering from benign prostatic hypertrophy.
Patients of RVD and HBsAg.
Pregnant women and lactating mother.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the role of Yavakshara in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection.  2 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Yavakshara in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection.
To evaluate the efficacy of Chandraprabha Vati in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection.
To compare the efficacy of Yavakshara and Chandraprabha Vati in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection.
 		 2 Weeks 
 
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)   13/05/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsatenderchauhan@gmail.com].

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 30-04-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Mutrakrichra is a condition which is characterized by difficulty in micturition1. Ayurvedic texts described 8 types of Mutrakrichra among them Pittaja Mutrakrichra is clinically characterized by features like Peetamutrata (Yellowish urine), Saraktamutrata (Hematuria), Sarujamutrata (Dysuria), Sadahamutrata (Burning micturition), Muhurmuhurmutrata (Frequency) 2 resembles to features of Lower Urinary Tract Infection in Modern science.

Urinary Tract Infection (U.T.I.) is one of the most common and prevalent infection in the community 3.The UTI prevalence was 53.82% in patients; however, the prevalence was significantly higher in females than in males. Females within the age group of 26-36 years and elderly males of ≥48 years showed higher prevalence of UTI. Gram negative bacteria (90.32%) were found in high prevalence than Gram positive (9.68%). Escherichia coli (42.58%) was the most prevalent gram negative isolate 4.An estimated 50% of women experience at least one episode of UTI at some point in their lifetime and between 20% and 40% of women have recurrent episodes 5.

Lower Urinary tract infection can be defined as infection to lower urinary tract with pain, frequency, hematuria and pyuria 6. The Modern science manages this condition with antibiotics, antispasmodics and alkalisers.

In classics various treatment modalities for Mutrakrichra are explained and among them in Bhaishajya Ratnavali Yavakshara with Madhu is indicated for Mutrakrichra7.Yava is having properties like Kaphapittahara, Mutralaprabhava. Yavakshara is having properties such as Raktasthambaka8, Vedanahara due to Vataharaguna9, Dahasamaka due to Saumya Guna10 and Mutrala11. Hence it is taken as study drug.

In Bhaishajya Ratnavali Chandraprabha Vati is indicated for Mutrakrichra, Hence it is taken as the standard drug12.

Thus keeping the above said concept in mind and as few research works done on Mutrakrichra and high prevalence rate, the present study is undertaken to evaluate the effect of Yavakshara and Chandraprabha Vati in the management of Pittaja Mutrakrichra with special reference to Lower Urinary Tract Infection (L.U.T.I.).

 
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