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CTRI Number  CTRI/2018/07/014983 [Registered on: 20/07/2018] Trial Registered Prospectively
Last Modified On: 18/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Randomized open label cross over design study 
Study Design  Randomized, Crossover Trial 
Public Title of Study   “DESIGNING AUTOMATED MODIFIED SITZ BATH INSTRUMENT” 
Scientific Title of Study   “DESIGNING AND VALIDATION OF AUTOMATED THERMOREGULATORY AVAGAHA SWEDA YANTRA WITH SPECIAL REFERENCE TO SITZ BATH” 
Trial Acronym  DAVOATAYWSRTSB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MANDEEP SINGH 
Designation  PG SCHOLAR (shalya tantra) 
Affiliation  KAHERS Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center 
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center Nathpai Circle, Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  7307374073  
Fax    
Email  drmandeepsingh029@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MANDEEP SINGH 
Designation  PG SCHOLAR (shalya tantra) 
Affiliation  KAHERS Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center 
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center Nathpai Circle, Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  7307374073  
Fax    
Email  drmandeepsingh029@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amruta Wali 
Designation  Associated Professor Department of Shalya Tantra 
Affiliation  KAHERS Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center 
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center Nathpai Circle, Shahapur Belagavi 590003

Belgaum
KARNATAKA
590003
India 
Phone  7411058509  
Fax    
Email  amrutawali.net@gmail.com  
 
Source of Monetary or Material Support  
KAHERS Shri BMK Ayurveda Mahavidyalaya Post graduate And Research Center 
 
Primary Sponsor  
Name  KAHERS Shri BMK Ayurveda Mahavidyalaya PG studies and research center  
Address  KAHERS Shri BMK Ayurveda hospital And Research Center, Shahapur belagavi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Amruta Wali  KAHERS Shri BMK Ayurveda Hospital And Research Center Shahapur Belagavi 
Dr Anil Koralli  KAHERS Shri BMK Ayurveda Hospital And Research Center, Shahapur Belagavi 
Dr Raviraj Havaldar  KLEs Dr M S Sheshgiri College of Engineering and technology belagavi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mandeep Singh  KAHERS Shri BMK Ayurveda hospital And Research Center  Department of Shalya tantra OPD no.8 and IPD KAHERs Shri BMK Ayurveda Hospital and Research center shahapur belagavi 590003
Belgaum
KARNATAKA 		 7307374073

drmandeepsingh029@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Ano-rectal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients advised for sitz bath. 
 
ExclusionCriteria 
Details  1. Diagnosed cases of Systemic diseases
like Tuberculosis, HIV, HBsAg
2. Patients unable to sit over Avagaha
yantra, like
 Locomotive disability
 Obese patients
 Mentally challenged individuals
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
for Comfortability and Satisfaction of patient

1. Comfort of Sitting
2. Operative system
3. Serving the purpose
 		 two years

 
 
Secondary Outcome  
Outcome  TimePoints 
Functionality of yantra
1. Portability and installation
2. Mechanical functions
3. Serving the purpose
 		 two years 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/09/2018 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

TITLE OF THE TOPIC:

 

“DESIGNING AND VALIDATION OF AUTOMATED THERMOREGULATORY AVAGAHA SWEDA YANTRA WITH SPECIAL REFERENCE TO SITZ BATH”

NAME OF THE CANDIDATE        :           Dr. MANDEEP SINGH.
    AND ADDRESS                                       1st YEAR M.S. Department of Shalya Tantra KAHER’S Shri B. M. K. Ayurveda Mahavidyalaya, Shahapur, Belgaum-590003, Karnataka

GUIDED BY-                                    Dr AMRUTA WALI  MS AYURVEDA  ASSISTANT PROFESSOR DEPARTMENT OF SHALYA TANTRA



 
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