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CTRI Number  CTRI/2024/02/062307 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 20/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the efficacy of chitraka kshara sutra with apamarga kshara sutra in the treatment of bhagandara(Fistula in ano) 
Scientific Title of Study   A controlled clinical study to evaluate the effect of Arka ksheera based Chitraka kshara sutra over Apamarga kshara sutra in the management of Bhagandara (Fistula in ano). 
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. Nikhil Sood 
Designation  Second Year PG scholar 
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal 
Address  Department of post graduation studies in Shalya Tantra.Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal.

Koppal
KARNATAKA
583231
India 
Phone  9591058858  
Fax    
Email  nikhil.s14698@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Geetanjali hiremath 
Designation  Associate Professor  
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal 
Address  Department of post graduate studies in Shalya tantra, Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, koppal

Koppal
KARNATAKA
583231
India 
Phone  7760346752  
Fax    
Email  sanjalihiremath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetanjali hiremath 
Designation  Associate Professor  
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital, Koppal 
Address  Department of post graduation studies in Shalya tantra. Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital,Koppal

Koppal
KARNATAKA
583231
India 
Phone  7760346752  
Fax    
Email  sanjalihiremath@gmail.com  
 
Source of Monetary or Material Support  
Shree jagadguru gavisiddheshwara ayurvedic medical college post graduate studiesand research centre 
 
Primary Sponsor  
Name  Shree jagadguru gavisiddeshwara ayurvedic medical college postgraduate studies and research center 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college postgraduate studies and research center, Gavimath Campus,opp. toGavimath 
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 
Dr Nikhil Sood  Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center  Department of Shalya Tantra Room No 16 Koppal KARNATAKA
Koppal
KARNATAKA 
9591058858

nikhil.s14698@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICECSJGAMCH  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-kShArasUtra, क्षारसूत्र (Procedure Reference: 14VD shri Santosh kumar sharma Rasakamadhenu compiled by sri chudamani misra with suvivrtti Hindi commentary Edited Acharya shri Gularj sharma Mishra chaukhambha Orientalia Reprinted edition 2010 uttarardha 48 124 128 pg 322 323., Procedure details: Arka Ksheera based Chitraka Kshara sutra ligation Kshara Sutra will be changed once in every week till 7 weeks)
2Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: 14VD shri Santosh kumar sharma Rasakamadhenu compiled by sri chudamani misra with suvivrtti Hindi commentary Edited Acharya shri Gularj sharma Mishra chaukhambha Orientalia Reprinted edition 2010 uttarardha 48 124 128 pg 322 323, Procedure details: Arka Ksheera based Chitraka Kshara sutra ligation Kshara Sutra will be changed once in every week till 7 weeks )
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either gender diagnosed with all Low Anal Fistulae except suprashincteric fistula.
Equal to or within 5cm Tract length of fistula
 
 
ExclusionCriteria 
Details  High Anal Fistulae Complicated Fistula multiple Fistula Extra-sphincteric Fistula.
Secondary Fistula in ano due to Ulcerative colitis Crohns disease Tuberculosis Carcinoma of rectum and Patients with systemic illness like Uncontrolled Diabetes mellitus Hypertension and if tract length is more than 5 cm.
HIV and HbsAg positive patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Arka ksheera based Chitraka Kshara sutra in terms of time taken by kshara sutra to cut through the tract with the application of unit cutting time formula.  7 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence of Bhagandara treated with Arka ksheera based Chitraka kshara sutra.  7 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   20/02/2024 
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="10"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Fistula-in-ano is a tract lined by granulation tissue which connects perianal skin superficially to anal canal; anorectum or rectum deeply. It usually occurs in a pre-existing anorectal abscess which burst spontaneously. Fistula-in-ano can be Cryptoglandular (90%) and Non cryptoglandular (10%).Fistula-in-ano according to park’s classification; Intersphincteric, Transphincteric, Suprasphincteric, Extrasphincteric. It is having clinical features like one or more external openings may be present with induration of the surrounding skin, seropurulent discharge and pain.1

In modern surgical treatment of Fistula in ano are Fistulotomy, Fistulectomy, Gluing of the Fistula tract, Anal Fistula Plug (AFP), Advancement flaps, LIFT technique, VAAFT procedure and Seton technique.2

Fistula in ano has been a troublesome disease to both patient and Physician to cure because of its recurrence rate. Fistula in Ano at modern parlance is a common anorectal condition prevalent in the populations worldwide. The overall incidence is about 9 cases per 100,000 population per year and those in their third, fourth and fifth decades of life are most commonly affected3. And is more common in young adult males than females with the ratio of 2:1 respectively.4

Bhagandara is a disease which causes tear or discontinuity in the region of Bhaga, Guda and Basti. According to Acharya Sushrutha, Bhagandara is a condition which is developed from bursting of painful and suppurated Pidika. He clearly differentiated the Bhagandara Pidika with other Pidika stating that if the Pidika is within two fingers area of Guda (anus), deep rooted, with pain and fever, it should be considered as Bhagandara Pidika.5Bhagandara (fistula-in-ano) is one among the most common anorectal disease.

It can be correlated with fistula-in-ano because of its similar clinical features. Five types of Bhagandara have been described as Shataponaka (Vataja), Ushtragreeva (Pittaja), Parisravi (Kaphaja), Shambhukavarta (Tridoshaja), Unmargi (agantuja).6Anorectal diseases like Bhagandara (fistula in ano) is said callous to be cured and Acharya Sushrutha had have considered Bhagandara one among the Ashta Mahagadas (eight grave disorders). Bhagandara is one of the oldest disease in Medical Science to be known.7

In modern world the medical science is so advanced in all aspects of treatments and surgical procedures but still the treatment for the fistula-in-ano is not yielding satisfactory results because of its high reccurrence rate. Kshara Sutra is one of the chief modalities in the treatment of Bhagandara in Ayurvedic science.8Exploration of the new plants for the preparation of Kshara as a better substitute to Apamarga Kshara is the need of the hour as it is available in the beginning of the year but Chitraka is available throughout the year. The idea came in mind to include Chitraka Kshara in place of Apamarga Kshara in making kshara sutra. To find out an effective alternative to Apamarga kshara sutra9 in view of easy availability throughout the year and attempt will be made to check the early healing of fistulous tract, an Arka ksheera based Chitraka kshara sutra10 over Apamarga kshara sutra were opted for their clinical evaluation.

 
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