| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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: - |
|
|
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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 |
|
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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 |
|
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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 |