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CTRI Number  CTRI/2024/08/072438 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Papaya Yava Ksharasutra In The Management Of Fistula In Ano 
Scientific Title of Study   A Randomised Controlled Trial To Evaluate The Effect Of Erandakarkati Yava Ksharasutra 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  Parveen Kumar  
Designation  Post Graduate Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department Of Shalya Tantra, Room no 8, OPD Block ,Sri Jayendra Saraswathi Ayurveda College ,Nazarthpet,Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9996591843  
Fax    
Email  write2chahal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Udayakiran 
Designation  Professor and HOD ,Department of PG studies in shalya tantra 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department Of Shalya Tantra, Room no 8, OPD Block ,Sri Jayendra Saraswathi Ayurveda College ,Nazarthpet,Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9849666054  
Fax    
Email  dr_tenneti@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr T Udayakiran 
Designation  Professor and HOD ,Department of PG studies in shalya tantra 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department Of Shalya Tantra, Room no 8, OPD Block ,Sri Jayendra Saraswathi Ayurveda College ,Nazarthpet,Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9849666054  
Fax    
Email  dr_tenneti@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College And Hospital Nazarthpet, Ponamalle, Chennai, Tamilnadu Pin code -600123 
 
Primary Sponsor  
Name  Parveen Kumar 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarthpet, Ponamalle ,Chennai Tamilnadu Pin code -600123 
Type of Sponsor  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 Parveen Kumar  Sri Jayendra Saraswathi Ayurveda College And Hospital Nazarthpet, Ponamalle  Department Of Shalya Tantra,Room no.8,OPD Block
Thiruvallur
TAMIL NADU 		 9996591843

write2chahal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital,Dept. of Ayurveda of SCSVMV, Nazarethpet, Chennai-600123  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
1Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: shushruta samhita chiktsasthana-17 verse no-29, Procedure details: A long metallic malleable probe with an eye will be introduced through external opening and attempted to pass the probe tip through the internal opening. The eye of the probe was threaded with Ksharasutra. Following this the two ends of the thread were snugly tied using two knots outside the anal canal)
2Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Shushruta samihta chikitsasthana 17 and Shyam Purushottam Warma(2019).Comparative Clinical Study On Effect Of Erandakarkati Ksheerasutra with Apamarga Ksharasutra in the management of Bhagandaraa (Fistula-In- Ano)- Dept. of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, Hassan, [Cited 2023 Aug 20]. , Procedure details: Erandakarkati ksheera & yava Ksharasutra will be used as per standard operative procedure under complete sterilization . Thread will be changed weekly as per rail road method till to t complete cut of the tract.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfiling clinical sign and symptoms of Bhagandara. 
 
ExclusionCriteria 
Details  HBsAg, HIV-positive patients.
Patients suffering from secondary fistulas due to Crohn’s disease, ulcerative colitis, carcinoma, and tuberculosis.
Patients having uncontrolled DM & HTN. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete healing of the fistula tract with healthy granulation tissue.  8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
complete healing of the fistula tract without any re-occurrence  after complete healing of tract patient will be advised to visit 14th 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/08/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 19-08-2024 and end date provided 19-08-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Bhagandara  is one of the Ashtamhagada. In modern science, it is correlated with Fistula in ano. the prevalence rate of fistula in ano is 8.6 cases for every 100,0000 populations. Appropriate treatment is based on 3 central tenets namely, control of sepsis, closure of the fistula and maintenance of continence. Ksharasutra technique allows complete healing of the fistula in 94% of patients. Erandakarkati which is abundantly available has been taken for preparing Ksharasutra in this study. It contains a chemical named papain which is alkaloid in nature. Yava Kshara is well known for its Lekhana action. Some study on Erandakarkati based Ksharasutra application has been done previously but more data is required to prove its effectiveness. Therefore, it is planned to evaluate the effect of Erandakarkati Yava Kshara Sutra in the management of Bhagandara. 
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