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CTRI Number  CTRI/2024/10/075405 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To See The Effect Of T-Shape Incision Mention In Ayurveda Followed By Cauterisation In The Managemnet Of Fistula-In-Ano. 
Scientific Title of Study   An Open Label Single Arm Clinical Study To Revalidate Sushrutokta Langalaka Incision Followed By Agnikarma In Vataja Bhagandara 
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 ROHIT  
Designation  PG SCHOLAR 
Affiliation  Rajiv Gandhi University Of Health Sciences,Banglore. 
Address  Room No 10 Department of PG And Ph.D Studies in Shalya Tantra JSS Ayurveda Medical College and Hospital #41/E Lalithadripura, Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9663669508  
Fax  08212548360  
Email  rohitshulsoor50@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SIDDAYYA ARADHYAMATH 
Designation  Head and Professor 
Affiliation  Rajiv Gandhi University Of Health Sciences,Banglore. 
Address  Room No 10 Department of Shalya Tantra JSS Ayurveda Medical College and Hospital #41/E Lalithadripura Mysuru - 570028

Mysore
KARNATAKA
570028
India 
Phone  9449972788  
Fax  08212548360  
Email  drsiddesharadhyamath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SIDDAYYA ARADHYAMATH 
Designation  Head and Professor 
Affiliation  Rajiv Gandhi University Of Health Sciences,Banglore. 
Address  Department of Shalya Tantra JSS Ayurveda Medical College and Hospital #41/E Lalithadripura Mysuru - 570028

Mysore
KARNATAKA
570028
India 
Phone  9449972788  
Fax  08212548360  
Email  drsiddesharadhyamath@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura Road, Mysuru- 570028 
 
Primary Sponsor  
Name  DR ROHIT 
Address  Department of PG Studies in Shalya Tantra, JSS Ayurveda Medical College and Hospital, 41/ E, Lalithadripura Road, Mysuru, Karnataka, 570028 
Type of Sponsor  Other [Other (Self)] 
 
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 ROHIT  JSS Ayurveda Medical College and hospital  Department of PG And Ph.D Studies in Shalya Tantra JSS Ayurveda Medical College and Hospital #41/E Lalithadripura Mysuru 570028
Mysore
KARNATAKA 
9663669508

rohitshulsoor50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Cedanakarma, छेदनकर्म followed by Agni karma (Procedure Reference: : Bhagandara chikitsa adhaya 8 Sushruta Samhita Chikitsa Sthana, Procedure details: Pre-operative procedures: Physical fitness will be taken. Consent will be taken. Subject will be kept NBM 6 hours prior to surgery. Part preparation. Proctoglycerin enema. Injection TT 0.5 ml IM will be given stat. Injection Lignocaine 2% test dose 0.1ml subcutaneous will be given. Operative procedures: Under Spinal anesthesia with strict aseptic precautions, the part will be painted and draped in lithotomy position. Fistulous tract will be identified & Probed. Length & Direction of the Fistula tract will be noted. Langalaka incision (T-shaped) will be taken over the external opening of the Fistula track followed by Agni karma using Bipolar Cautery. The same procedure will be carried out for other Fistula tracts. Complete Heamostasis will be achieved. Dressing will be done using Jatyadi Taila. Post-operative procedures: Subject will be shifted to post operative ward. Foot end elevation. Restricted head movements will be adviced. The vitals will be monitored every 2 hrly. Catheterization will be done. Oral liquids will be started after 4 - 6 hours of surgery. Tab. Gandhaka Rasayana(2-0-2)A/F Tab Triphala Guggulu (2-0-2)A/F Triphala choorna 20gms will be given before food at night with lukewarm water. The study with a single group consisting of 30 subjects. Total study duration is -42 days. )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects with Vataja Bhagandara with multiple opening around the anal canal.
2.Subjects with Recurrent Anal Fistula.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women.
2.Diagnosed cases of High Anal Fistula connected to PNS, Rectovesical Fistula, Rectovaginal Fistula and Rectoscrotal Fistula.
3.Fistula caused secondary to Tuberculosis, Crohn’s disease, Ulcerative colitis, CA of Rectum,HIV and Hepatitis B.
4.Uncontrolled DM and other Systemic disorders. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The prime aim of the treatment is to eradicate the tract and drain all collections from the site of infection while preserving anal continence and minimize the re-occurrence.   1st, 7th, 14th, 21st and 28th day  
 
Secondary Outcome  
Outcome  TimePoints 
To Revalidate the Langalaka incision in Vataja Bhagandara.

 
1st, 7th, 14th, 21st and 28th day  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
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  

Bhagandara is a condition which has been recognized as a difficult surgical disease in  the ancient and modern medical sciences of the world, because the recurrent nature of this disease which makes it more and more difficult for treatment. The most scientific description about Bhagandara is given in Sushruta SamhitaBhagandara is a chronic illness which can be co-related to Fistula-in-Ano, though it is not fatal but quite discomforting and troublesome to the patient, it also imposes a psychological stress on the patient.The incidence of Fistula-in-Ano developing from an anal abscess ranges from 26% to 38%, the prevalence rate of  Fistula-in-Ano is 8.6 cases per 100,000 population worldwide. In the men the prevalence is 12.3 cases per 100,000 population and in woman it is 5.6 cases per 100,000 population.Despite of  many advancements in the surgical fields, the treatment of Fistula-in-Ano still remains a great challenge. During the last century, numerous surgical procedures like Fistulectomy, Fistulotomy, Advancement Flaps, Fistula Clip Closure, LIFT technique, VAAFT procedure, Anal Fistula Plug Repair, Fibrin Glue and Seton Techniques, each of these carries significant risk of pain, delayed wound healing, incontinence and re-occurrence.The prime aim of the treatment is to eradicate the tract and drain all collections from the site of infection while preserving anal continence and minimize the re-occurrence. This has led  surgeons to switch to alternative surgical modalities of treatment like Ksharasutra and Agni karma procedures.Even when we go through the classics different varieties of incision has been explained by Acharya Sushruta and Acharya Vagbhata for Bhagandhara. In the management of Vataja Bhagandara  Acharyas  have described Chedana karma of interconnected Fistulae with multiple opening using 4 types of incisions namely, Langalaka (T-shape), Ardha Langalaka (L-Shape), Sarvatobhadraka  (Circular-shape) and Gotirthaka (S-shape). Langalaka  means ‘Hal’ i.e. plough used by farmer in field. The incision have two arm perpendicular to each other and extending on either side like ‘T’ shaped, the interconnected tracts can be easily probed and incised on either side using this Langalaka incision. This emphasizes Acharya Sushruta’s wide knowledge about the disease manifestation, management and complications in Vataja Bhagandara .The current Ayurvedic surgical approach for Bhagandara includes Ksharasutra, Partial Fistulectomy and IFTAK. So far, no research work has been carried out to evaluate the efficacy of  Langalaka incision in Vataja Bhagandara. Hence, an attempt will be made to revalidate the Langalaka incision in Vataja Bhagandara.

              Sample Size:

The study with a single group consisting of 30 subjects.

Pre-operative procedures:

·       Physical fitness will be taken.

·       Consent will be taken.

·       Subject will be kept NBM 6 hours prior to surgery.

·       Part preparation.

·       Proctoglycerin enema.

·       Injection TT 0.5 ml IM will be given stat.

·       Injection Lignocaine 2% test dose 0.1ml subcutaneous will be given.

 Operative procedures:

·       Under Spinal anesthesia with strict aseptic precautions, the part will be painted and draped in lithotomy position.

·       Fistulous tract will be identified and Probed. Length & Direction of the Fistula tract will be noted.

·       ‘Langalaka’ incision (T-shaped)  will be taken over the external opening of the  Fistula track followed by Agni karma  using Bipolar Cautery.

·       The same procedure will be carried out for other Fistula tracts.

·       Complete Heamostasis will be achieved.

·       Dressing will be done using Jatyadi Taila.

 

Post-operative procedures:

·       Subject will be shifted to post operative ward.

·       Foot end elevation.

·       Restricted head movements will be adviced.

·       The vitals will be monitored every 2 hrly.

·       Catheterization will be done.

·       Oral liquids will be started after 4 - 6 hours of surgery.

·       Tab. Gandhaka Rasayana(2-0-2)A/F

·       Tab Triphala Guggulu (2-0-2)A/F

·       Triphala choorna 20gms HS will be given before food with lukewarm water.

                



 
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