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CTRI Number  CTRI/2017/12/010904 [Registered on: 18/12/2017] Trial Registered Retrospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management Of Renal Calculi with Gaumutra kshara 
Scientific Title of Study   EFFECT OF GAUMUTRADI KSHARA IN THE MANAGEMENT OF MOOTRASHMARI W.S.R TO RENAL CALCULI 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhimant bhatt 
Designation  PG Scholar 
Affiliation  Parul institute of Ayurveda 
Address  Parul institute of Ayurveda, Department of shalya tantra,parul university,limda.vadodara.Gujarat.391760.India

Vadodara
GUJARAT
391760
India 
Phone  9724967007  
Fax    
Email  dhimant.dhimantbhatt.bhatt7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrHemant Toshikhane 
Designation  H.O.D 
Affiliation  Parul institute of Ayurveda 
Address  Parul institute of Ayurveda, Department of shalya tantra,parul university,limda.vadodara.Gujarat.391760.India

Vadodara
GUJARAT
391760
India 
Phone  8469496525  
Fax    
Email  hemant.toshikhane@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  DrHemant Toshikhane 
Designation  H.O.D 
Affiliation  Parul institute of Ayurveda 
Address  Parul institute of Ayurveda, Department of shalya tantra,parul university,limda.vadodara.Gujarat.391760.India


GUJARAT
391760
India 
Phone  8469496525  
Fax    
Email  hemant.toshikhane@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
parul ayurveda hospital and Parul University Limda Vadodara Gujarat 
 
Primary Sponsor  
Name  parul institute of ayurveda and hospital 
Address  parul university,limda,vadodara,gujarat-391760 
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 
dhimant bhatt  parul ayurveda hospital  parul institute of ayurveda,And Parul Ayurveda Hospital Shalya Tantra opd Room no 116 At Limbda Vadodara,Gujarat university,limda,vadodara,gujarat.
Vadodara
GUJARAT 
9724967007

dhimant.dhimantbhatt.bhatt7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gaumutradi kshara   250mg Oral route Three times a Day with Lukewarm water for 60days  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having classical signs and symptoms of Mootrashmari (Renal calculi)
2.Size of calculus less than 10 mm will be taken.
3.Patients age between 16 to 60 years.
4.Bilateral and unilateral renal calculi
 
 
ExclusionCriteria 
Details  • Patient having Urinary Calculus of size more than 10mm.
• In case, Patient requires immediate surgical intervention.
• Chronic systemic illness, DM,HTN, HIV,& other renal diseases
• Pregnant & Lactating women.
• Vesicle calculi
• Ureteric calculi,
• Patients who are contraindicated for kshara administration
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in the size of renal calculi aftr taking trial medicine  reduction in the size of renal calculi and get symptomatic relief after taking medicine regularly for 7 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
decrase in pain,burning micturation,nausea,vomitting  60days 
 
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 1 
Date of First Enrollment (India)   01/05/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Publication prepared after complication of trial  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Mankind has been affected by renal calculi since centuries, and has been the silent cause of renal failure also. In India the disease affect all age group, source of morbidity 80% those with Renal calculi  are man,(6) approximately 5-7 million patients suffer from Renal calculi  disease and at least 1/1000 of Indian population need hospitalization due to Renal calculi disease. Thus the disease is a wide spread, particularly in countries with dry, hot climate, these” stone belt regions ”of the world are located in countries of middle east, North Africa , the Mediterranean region, North Western states of India and Southern states of USA and area around the great lakes. In India, the stone belt occupied parts of Maharashtra, Gujarat, Punjab, Haryana, Delhi, Rajasthan etc .In these regions the disease is so prevalent that most of the family will suffer from Renal calculi sometime in their lives.(7)

There is no any specific medical treatment for renal calculi in modern medicine. None of modern methods have provided the final solution for renal calculi. So in this condition most effective and curative treatment is required.

  In Ayurveda various formulation are mentioned for the Mootrashmari management viz. Kshara (Paniya Kshara) (8) etc.as it mentioned in Ayurvedic text that kshara has guna karma of chedna, bhedna, lekhna.(9)so, it  have been used effectively and economically on Mootrashmari. No research found on evaluate effect of Gaumutradi kshara in the management of Mootrashmari So,study on “Effect of Gaumutradi kshara in the management of Mootrashmari w.s.r to Renal calculi” is undertaken.

 
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