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CTRI Number  CTRI/2025/02/080934 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Intervention in the Management of Kidney Stones 
Scientific Title of Study   A Comparative Clinical Study to evaluate the effect of Varunadi Taila and Kulattadhya Ghrita Matrabasthi followed by Swadamshtradi Kwatha in Mootrashmari Vis-a-Vis Urolithiasis 
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 POOJA BG 
Designation  Post Graduate Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devaraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  6363681618  
Fax    
Email  bgpooja06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ANNAPOORNA S 
Designation  Assistant professor department of kayachikitsa 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devaraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  9449511110  
Fax    
Email  annapoorna20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR POOJA BG 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and Hospital Mysore 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Vishweshwaraiah Circle Devaraj Mohalla Mysore Karnataka 570001 India

Mysore
KARNATAKA
570001
India 
Phone  6363681618  
Fax    
Email  bgpooja06@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital Mysore Karnataka India 570001 
 
Primary Sponsor  
Name  DR POOJA BG 
Address  Post Graduate Department of Kayachikitsa Government Ayurveda Medical College and Hospital Mysore 
Type of Sponsor  Other [SELF] 
 
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 POOJA BG  Government Ayurveda Medical College and Hospital Mysore  Room Number 10 Kayachikitsa Outpatient Department and Inpatient Wards of Government Ayurveda Medical College and Hospital Mysore Karnataka 570001 India
Mysore
KARNATAKA 
6363681618

bgpooja06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda Medical College ,Mysore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Varunadi Taila, Reference: Chakradatta Ashmari Chikitsa 34 chapter 49 shloka, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Kulattadhya Ghrita, Reference: Chakradatta Ashmari Chikitsa 34 chapter 38 Shloka, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Swadamshtradi Kashaya, Reference: Bhavaprakasha Madhyakanda 37 Adhikara 70 shloka, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects diagnosed to have urinary calculi (solitary or multiple) by USG Abdomen and pelvis will be included in the study
Stones measuring less than 8mm by USG Abdomen and pelvis will be included
Fresh and treated cases of Mootrashmari vis a vis Urolithiasis will be taken for the study
Fresh cases including freshly detected and untreated cases of Mootrashmari vis a vis Urolithiasis
Treated cases including individuals those who are under any treatment of Mootrashmari vis a vis Urolithiasis and are willing to voluntarily discontinued the ongoing treatment will be considered in those cases flush out period of 1 week will be advised with repeat USG abdomen and pelvis 
 
ExclusionCriteria 
Details  Subjects with acute urinary colic which requires emergency management will be exchuded
Subjects with impaired renal function test, Severe hydronephrosis, Oliguria/Anuria and complications requiring surgical management will be excluded
Subjects with uncontrolled systemic disorders that might interfere with present intervention will be excluded.
Pregnant and Lactating mothers will be excluded from the study.
Subjects who are unfit for Basthikarma will be excluded 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluating the efficacy of varunadi taila and kulattadhya ghrita Matrabasthi with Swadamshtradi Kashaya in relieving the symptoms of Mootrashmari like Hematuria ,pain abdomen, Burning micturition and difficulty in passing urine with size and number of the stone through pre and post test USG Abdomen and Pelvis   Evaluating the efficacy of varunadi taila and kulattadhya ghrita Matrabasthi with Swadamshtradi Kashaya in relieving the symptoms of Mootrashmari like Hematuria ,pain abdomen, Burning micturition and difficulty in passing urine with size and number of the stone through pre and post test USG Abdomen and Pelvis
0th day and 38th day 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing the efficacy of varunadi taila and kulattadhya ghrita Matrabasthi with Swadamshtradi Kashaya in relieving the symptoms of Mootrashmari like Hematuria ,pain abdomen, Burning micturition and difficulty in passing urine with size and number of the stone through pre and post test USG Abdomen and Pelvis   0th day before the intervention USG Abdomen and Pelvis and on 39th day repeating USG Abdomen and pelvis after completion of intervention 
 
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   Phase 3 
Date of First Enrollment (India)   19/02/2025 
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="1"
Months="0"
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  
Mootrashmari is defined as formation of a stone like substance in Mootravaha srotas with symptoms like Mahati vedana Sarudhira mootrata Vedana in Nabhi and Basthi pradesha and  Mootradhara sanga In Sushruta samhitha  Mootrashmari is considered as one among the Ashta Mahagada

Majority of signs and symptoms of the disease Mootrashmari resembles that of Urolithiasis Urolithiasis is a condition where hard masses or calculi is formed and get collected in the urinary tract characterized by dull aching pain in both loins hematuria frequent micturition and difficulty in passing urine It is the third most common affliction of the urinary tract with a prevalence of about 12% worldwide Their prevalence in India also reflects worldwide prevalence and stands at approximately 12% Men are more commonly affected than female with a male to female ratio of 3:1 The peak age for developing calculi is between 30-50yrs. 7 Recurrence is common with 10% risk at lyear, 35% at 5year and nearly 50% at 10years

Untreated Urolithiasis can encompass complications like Acute renal failure resulting from obstruction  Anuria Urinary tract infection Sepsis and elevate the risk for Chronic kidney disease The treatment principle of Urolithiasis in contemporary science is flush therapy in case of stones up to 5mm in larger stones the advanced procedures like ESWL(Extracorporeal shock wave lithotripsy) and operative procedures like Percutaneous nephrolithotomy Pyelolithotomy Nephrolithotomy Nephrectomy are done But these procedures have limitations in various aspects like they are expensive invasive and many a times leads to complications such 16 as injury to colon injury to blood vessels and sepsis In Sushruta Samhita conservative management is emphasized in the initial stages of Ashmari and surgery in the longstanding complicated conditions In Ayurveda Basthikarma is considered as the prime modality and said to be Ardachikitsa 13 indicated in all Ekadoshaja Samsargaja Sannipataja disorders

Much importance is given to Trivida Bastikarma Niruha Anuvasana Uttara in the 14 management of Mootravahasrotovikara Ashtanga Sangraha explains the repeated 15 administration of Basti in the management of Mootrashmari Matra basti is one of the  subclasses of Basti Karma which is easy to administer without much limitations or 17 complications Though numerous studies have been conducted on the management of Mootrashmari, yet studies focused on Matrabasti are very less.

In Chakradatta, while discussing various formulations for Ashmari it is mentioned that Kulattadhya Ghrita and Varunadi Taila have properties like Sarva Prakara Ashmarihara and Ashmari Bhedana respectively. In Bhavaprakasha Swadamshtradi kwatha is said to have Ashmari shulaghna effects

The herbs mentioned in above said formulations are cost effective and widely accessible  Considering all the above factors the study to evaluate the efficacy of Varunadi taila and Kulattadhya ghrita Matrabasti followed by Swadamshtradi kwatha in Mootrashmari vis a vis Urolithiasis will be undertaken
 
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