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CTRI Number  CTRI/2023/06/054472 [Registered on: 27/06/2023] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Which Minimal Invasive Ksharasutra Technique is best in the management of Bhagandhara? 
Scientific Title of Study   A Randomized Clinical Study On Three Different Sub-techniques Of Minimal Invasive Kshara Sutra Technique In Bhagandhar With Special Reference To Transsphincteric Fistula-in-ano . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satya Santosh Sahoo 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda, Jaipur,Rajasthan 
Address  Department of Shalya Tantra ,National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 ,India
AT/PO- Raj Sunakhala , Dist- Nayagarh ,PS- Ranpur Odisha ,Pin- 752065 ,
Jaipur
RAJASTHAN
302002
India 
Phone  8249967650  
Fax    
Email  sahoosatya63@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof P Hemantha Kumar 
Designation  Professor , HOD Department of Shalya Tantra , PG Dean , NIA , Jaipur 
Affiliation  National Institute Of Ayurveda, Jaipur,Rajasthan 
Address  Department of Shalya Tantra ,National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 ,India
National Institute Of Ayurveda, Jaipur, Near Jorwar singh gate, Amer Road, Rajasthan, 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof P Hemantha Kumar 
Designation  Professor , HOD Department of Shalya Tantra , PG Dean , NIA , Jaipur 
Affiliation  National Institute Of Ayurveda, Jaipur,Rajasthan 
Address  Department of Shalya Tantra ,National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 ,India
National Institute Of Ayurveda, Jaipur, Near Jorwar singh gate, Amer Road, Rajasthan, 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Source of Monetary or Material Support  
OPD/IPD PG Department Of Shalya Tantra ,National Institute Of Ayurveda (Deemed To Be University) , Amer Road,Near Jorawar Singh Gate,Jaipur,Rajasthan , 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda Deemed To Be University (De-Novo) Jorawar Singh Gate Amer Road Jaipur Rajasthan – 302002 
Type of Sponsor  Research institution and hospital 
 
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 
Satya Santosh Sahoo  NIA HOSPITAL  OPD NUMBER - 28 National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 8249967650

sahoosatya63@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  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BHAGANDHAR, (2) ICD-10 Condition: K603||Anal fistula, (3) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, (4) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, (5) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrut Chikitsa Sthana 17 , Procedure details: Identify the fistulous track with the help of probe and an incision will be created in intersphincteric space or near the external sphincter and devide the fistulous track under direct vision and apply the Kshara Sutra between created incision and internal opening followed by Coring of the remaining fistulous track.)
2Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrut Chikitsa Sthana 17, Procedure details: Identify the fistulous track with the help of probe and an incision will be created in intersphincteric space or near the external sphincter and devide the fistulous track under direct vision and apply the Kshara Sutra between created incision and internal opening and remaining fistulous track will be left as it is.)
3Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrut Chikitsa Sthana 17 , Procedure details: Identify the fistulous track with the help of probe and an incision will be created in intersphincteric space or near the external sphincter and devide the fistulous track under direct vision and apply the Kshara Sutra between created incision and internal opening followed by application of plain thread in the remaining fistulous track for drainage purpose.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with Transsphicteric fistula-in-ano between the age group of 20 to
60 years of either sex.
2. Patients who have signs and symptoms of Bhagandhar /Fistula-in-ano of
length of the tract more than 4cm from anal canal.
3. Patients who have signs and symptoms of uncomplicated and Recurrent
Transsphincteric fistula. 
 
ExclusionCriteria 
Details  1. Transsphincteric fistula with a high blind track.
2. Patients with other systemic illnesses like uncontrolled Diabetesmellitus,
Hypertension,Malignancy,Hepatitis B, Tuberculosis and Retrovirus positive.
3. Infective and Neoplastic conditions of rectum, Rectal prolapse.
4. Patients having Pelvic pathology and Pregnancy.
5. Patients not fit for anaesthesia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Duration of Intervention (In minutes)
2. Change in pain score (VAS)
3. Change in discharge score
4. Change in wexner score (Incontinence)
5. Time taken for wound healing 		 Assessment on pre-op and 1st, 2nd, 3rd & 4th week of post-op period 
 
Secondary Outcome  
Outcome  TimePoints 
1. Length of Hospital stay.
2. Time to return to work.
3. Patient satisfaction (Quality of life). 		 Follow up period - 3 months (every 15th day) 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/07/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will
be selected. All the participants who voluntarily agree to participate and provide informed written
consent for participation will be recruited in the study.
Total 45 participants will be selected after details examination and divided in 3 groups of 15 patients
each as per study protocol. All Procedures will be executed under aseptic condition . Patient
will be taken for assessment initially in pre-op and on 1st, 2nd, 3rd and 4th week of post-op period thereafter on every 15th day upto next 3 months
 
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