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CTRI Number  CTRI/2022/03/041450 [Registered on: 29/03/2022] Trial Registered Prospectively
Last Modified On: 28/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   kshar sutra application in fistula in ano. 
Scientific Title of Study   A clinical study of interception of fistulous tract with application of ksharsutra (IFTAK) technique using madhu saindhav aragbadhadi ksharsutra in the management of bhagandara (cryptoglandular fistula). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohan Swarup Sharma 
Designation  M.S. Scholar 
Affiliation  Dr.SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVEDA UNIVERSITY JODHPUR 
Address  Room number 135 pg department of Shalya Tantra Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur
Room number 135 pg department of Shalya Tantra Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India 
Phone  8619308982  
Fax    
Email  tekchandparasar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumar Gupta 
Designation  Associate professor 
Affiliation  DSRRAU, Jodhpur 
Address  Room No. 134 PG Department of shalya tantra University College of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur
Room No. 134 PG Department of shalya tantra University College of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur
Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohan Swarup Sharma 
Designation  MS Scholar 
Affiliation  DSRRAU, Jodhpur 
Address  PG Department of shalya tantra,DSRRAU Jodhpur
PG Department of shalya tantra University college of ayurved, DSRRAU,Jodhpur
Jodhpur
RAJASTHAN
342037
India 
Phone  8619308982  
Fax    
Email  tekchandparasar@gmail.com  
 
Source of Monetary or Material Support  
OPD No-14 Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Hospital, Nagaur Road, JODHPUR 
 
Primary Sponsor  
Name  DSRRAU JODHPUR RAJASTHAN 
Address  Room No. 135 PG Department of shalya tantra University College of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur 
Type of Sponsor  Government funding agency 
 
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 Rajesh kumar gupta  DSRRAU Karwar,Jodhpur  OPD NO 14, University college of ayurved hospital,DSRRAU Jodhapur
Jodhpur
RAJASTHAN 
9636520573

guptadrrajeshkumargupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional cthics committee UCA jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: bhagandar, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IFTAK  Interception of fistulous tract with application of ksharsutra. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details   INCLUSION CRITERIA :
1.Blind fistula in ano.
2.Low anal fistula in ano.
3.All type tract of fistula in ano.
4.Recurrent fistula in ano.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA:
1.Fistula in ano present with tuberculosis.
2.Diabetes Mellitus.
3.Hypertension.
4.ChronicAmoebias
6.Osteomyelitis of pelvic bone/femur.
7.Regional Ileiti
9.Any malignancies related with fistula in ano.
10.Chronic/acute ulcerative Colitis.
11.HIV&HBsAg Positive patient.
12.Crohn’s disease
13.Faecal Fistula & Uretero-Vaginal Fistula
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the sign and symptoms of patients  12 month 
 
Secondary Outcome  
Outcome  TimePoints 
healing of fistulous tract  21 days 
 
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)   30/04/2022 
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="0"
Months="11"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

ShalyaTantra has wide scope in the management of Bhagandara(fistula-in-ano). Most recognized therapy for the management of Bhagandara is KsharaSutratherapy.AcharyaSushruta  has mentioned in NidanaSthana.According to modern science a fistula is a abnormal passage way between two organs of the body or between an organ and the exterior of the body. But we are concern here Bhagandara  means fistula in ano.

Fistula in ano is a condition which has been recognized as difficult surgical disease in all the ancient and modern medical sciences of the world. It is the recurrent nature of this disease which makes it more and  more difficult for treatment. It has been categories as a surgical condition and almost all the surgeons from Sushruta and also down to the modern reputed surgeons of present times have realized that difficult course which this disease offer for its surgical /medical /medico surgical methods of treatment. But a multi dimensional or divergent approach to the treatment for a single disease is only suggestive of the fact that none of these methods is complete and satisfactory. Even AcharyaSushruta have been realized the necessity of para-surgical approach. To overcome these recurrent nature of Bhagandara needs more and more comparative study. The present study is undertaken as mentioned in Chakradutta5th chapter “Arshachikitsaadhyaya”&46th chapter “Bhagandarachikitsaadhyaya”&Bhaisajyaratnavali 50thchapter“Nadivranachikitsaadhyaya”. Fistula in ano is an infective disease of anal canal usually caused by cryptoglandular infection  of anal crypts. In fistula in ano there is an abnormal communication between two epithelial surface and the track  is lined by unhealthy granulation tissue. Intercepion Of Fistulous Tract With Application Kshar sutra [IFTAK] technique with kshar sutra proved to be very effective and conduct interception of fistlous tract with application of kshar sutra.

interception of fistulous tract with application of kshar sutra (IFTAK) is being practiced for treating complex and recurrent fistula in ano. In this technique proximal part of fistulas track is intercepted at the level of external sphincter along with the application of kshar sutra from site of interception to the infected crypt in anal canal .This is aimed at to eradicate the infected anal crypt with minimal damage to anal sphincter by using ksharsutra (medicated seton).Use of ksharsutra cause extensive fibrosis and favour  proper healing which reduce the chance of reccurence. 

 
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