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CTRI Number  CTRI/2019/08/020891 [Registered on: 26/08/2019] Trial Registered Prospectively
Last Modified On: 13/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Other (Specify) [Phd thesis]  
Study Design  Single Arm Study 
Public Title of Study   Treatment of Kidney stone 
Scientific Title of Study   A pre & post test clinical study to Evaluate the combined effect of yoga basti karma and shaman yoga chikitsa in Ashmari (renal stone )based on sushrut protocol 
Trial Acronym  nil 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Astha verma 
Designation  BAMS,MD Kayachikitsa 
Affiliation  Mandsaur ayurvedic institute and research, 
Address  Mandsaur ayurvedic institute and research,B.R.Nahata pharmacy campus, Mandsaur.
206-B,Basant vihar colony, court road,dhar(MP) 454001
Dhar
MADHYA PRADESH
458001
India 
Phone  9479903622  
Fax  -  
Email  dr.asthaverma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRatnaprava mishra  
Designation  professor and HOD 
Affiliation  Mandsaur institute of Ayurveda education and Research Mandsaur 
Address  Mandsaur ayurvedic institute and research,B.R.Nahata pharmacy campus, Mandsaur university.
Mandsaur ayurvedic institute and research,B.R.Nahata pharmacy campus, Mandsaur university. 458001
Mandsaur
MADHYA PRADESH
458001
India 
Phone  918281931485  
Fax  -  
Email  drrpmishra@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRatnaprava mishra  
Designation  professor and HOD 
Affiliation  Mandsaur institute of Ayurveda education and Research Mandsaur 
Address  Mandsaur ayurvedic institute and research,B.R.Nahata pharmacy campus, Mandsaur university.
Mandsaur ayurvedic institute and research,B.R.Nahata pharmacy campus, Mandsaur university. 458001
Mandsaur
MADHYA PRADESH
458001
India 
Phone  918281931485  
Fax  -  
Email  drrpmishra@gmail.com  
 
Source of Monetary or Material Support  
Dr.Astha verma Mandsaur ayurved institute and researchMandsaur.BR Nahata Pharmacy campus, near krishi upaj mandi,Mandsaur (mp) 458001 
 
Primary Sponsor  
Name  Mandsaur ayurvedic institute and research 
Address  Mandsaur ayurvedic institute and research,B.R.Nahata Pharmacy campus, Mandsaur(m.p.) 
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 
drJayashankar munda  Mandsaur ayurvedic institute and research  Mandsaur ayurvedic institute and research,B.R.Nahata pharmacy campus, Mandsaur university. 458001
Mandsaur
MADHYA PRADESH 		 8075006757
-
principal.ayurved@meu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECMandsauruniversityMP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: B||Imaging,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A pre and post test clinical study to Evaluate the combined effect of yoga basti karma and shaman yoga chikitsa in Ashmari (renal stone )based on sushrut protocol  Yoga basti karma - FOR 8 DAYS sahacharadi oil 140 ml after meal is use under Anuvasan basti and Varunadi kwath used under Asthapan basti 750 ml before meal which comes under shodhan chikitsa. In Shaman yoga chikitsa varunadi kwath 90 ml in divided dose twice a day before meal, chandraprabha vati 250 mg bd with honey before meal ,gokshuradi guggul 1 gm bd after meal for 60 days . 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between 20 to 60 years of age irrespective of sex and occupation were included.
2. Size of the urinary calculi from 2 mm to 14 mm was included.

3. Calculus present in urinary tract , Kidney, ureter, lower part of urinary tract etc.
4. Patients having signs and symptoms of Ashmari were included viz. Urination,
5. Pain in the region of umbilicus, perineum and dome of bladder; experience of severe pain on movement of the urine was included.
6. Patient having Refer pain lower back to abdomen , in external genitalia and groin get burning sensation during urination or blood in urine and increase urge and frequency of urination.
7. Non- specific symptoms of stones in the kidney include Fever, Heamaturia, Nausea, vaomiting, burning micturation .  
 
ExclusionCriteria 
Details  1. Congenital obstructive defects of renal, pelvis and ureter.
2. Patient of Ashmari having systemic diseases like IHD, RHD, AIDS & other chronic diseases like TB and acute & chronic renal failures.
3. Pregnant women and lactating mother & patients below 20 years.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
breakdown of the calculus and expel out from the kidney itself.   60 days 
 
Secondary Outcome  
Outcome  TimePoints 
expel out of the kidney   expel out of the kidney with in 45 days or more  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/08/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 4 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
    Renal stone is a disease of the genitourinary system characterized by the formation of solid piece of minral salts present in urine. Kidney filters unwanted substances from body fluids, remove them in the form of urine and control chemical level. When this processes is abnormal and there is deposition of crystals like calcium, oxalate, uric acid etc then there is formation of different types, shape and colours of stones. 
   According to classics Vata is located in Pakvashya sthana which is main responsible factor for the elimination and reation of mala, mutra and other toxic particles. when this vata is aggrevated then it vitiate to all other doshas and dries up the shukra, mutra, pitta and kapha located in the basti pradesh and gradually stones are formed. According to sushrut, mutra enters into basti through the mutravahak nadies like mutra- vata, pitta and kapha also enters into the basti and furthur with upsneha nyaya Ashmari is formed.
    As here we used Yoga basti karma which is best treatment for pakvashayagata vata along with other vitiated doshas. In yoga basti, sahacharadi oil is use under Anuvasan basti and Varunadi kwath used under Asthapan basti which comes under shodhan chikitsa. In Shaman yoga chikitsa first Aushadh is varunadi kwath  having the property Kashaya, tikta rasatmaka, laghu, ruksha guna, ushna virya,katu vipaki helps in condition of dysuriya, retation of urine and maintain fever with all associated complain of renal stone ( Ashmari). Second Aushadha is chandraprabha vati is kapha vata shamak having sheelajeeta. maintain saptadhatu and all agni act as Rasayana or Kshar dravyas act as agni deepan, chedaniya, bhedaniya, lekhaniya properties, Third one is gokshuradi guggul having the tridoshaj property containing gokshur, guggula , triphala, trikatu, musta act as shoth hara, vata hara, mutral, lekhan or basti shodhan . here we find out a better management for Ashmari and evaluate the combine efficacy of yoga basti and shaman yoga chikitsa for breakdown of the calculas ( Ashmari bhedan) and expel out ( ashmari hara) from the kidney itself. 
 
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