FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079666 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of basthi followed by apamarga kshara sutra in bhagandara(fistula in ano) 
Scientific Title of Study   Efficacy of basthi followed by Apamarga Ksharasutra application in the management of Bhagandara ( Fistula in ano) A randomized control clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sreechand S R 
Designation  PhD Scholar 
Affiliation  KLEU B M K Ayurveda Mahavidyalaya Belgaum 
Address  KLEU B M K Ayurveda Mahavidyalaya Belgaum

Belgaum
KARNATAKA
590003
India 
Phone  9633158159  
Fax    
Email  sreechand@kleayurworld.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Shindhe 
Designation  Professor & HOD 
Affiliation  KLEU B M K Ayurveda Mahavidyalaya Belgaum 
Address  Department of shalyatantra KLEU B M K Ayurveda Mahavidyalaya Belgaum

Belgaum
KARNATAKA
590003
India 
Phone  9986331357  
Fax    
Email  pshindhe@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sreechand S R 
Designation  PhD Scholar 
Affiliation  KLEU B M K Ayurveda Mahavidyalaya Belgaum 
Address  KLEU B M K Ayurveda Mahavidyalaya Belgaum

Belgaum
KARNATAKA
590003
India 
Phone  9633158159  
Fax    
Email  sreechand@kleayurworld.edu.in  
 
Source of Monetary or Material Support  
KLEU B M K Ayurveda Mahavidyalaya Belgaum 
 
Primary Sponsor  
Name  Dr Sreechand S R 
Address  KLEU B M K Ayurveda Mahavidyalaya Belgaum Karnataka 590003 
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 Sreechand S R  KLEU BMK Ayurveda college & hospital   opd number 8 Department of shalyatantra KLEU B M K Ayurveda Mahavidyalaya & Hospital Belgaum
Belgaum
KARNATAKA 		 9633158159

sreechand@kleayurworld.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER Ethics Committee on Human Subjects   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: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: susrutha bhagandara chikitsa, Procedure details: Partial fistulectomy followed by primary threading by using no 20 barber thread Applying ksharasutra in post op day 3 Application of apamarga kshara sutra by using rail road techanique, every week ksharasootra will changed till complete cutting of tract Sitz bath dailyFollowed by dressing )
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: ashtanga hrudaya sutra stana,, Procedure details: Modified yoga basthi (prior to surgical procedure) anuvasana bsthi 1st 2ed 3rd,4th 5th day afternoon niruha bsthi 2ed ,3erd,4th day in empty stomach n Partial fistulectomy followed by primary threading by using no 20 barber thread Applying ksharasutra in post op day 3 Application of apamarga kshara sutra by using rail road techanique, every week ksharasootra will changed till complete cutting of tract Sitz bath dailyFollowed by dressing )
(1) Medicine Name: chiravilwadi kashaya basthi, Reference: sahasrayoga, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: pippalyadi anuvasana tailam, Reference: bhaishajya ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients above the age of 18 years and below 70 years irrespective of caste, gender, religion and socio-economic status.
Clinical signs and symptoms of all types of Bhagandara
All Bhagandara including Recurrent Fistula- in-Ano
Patients fit for surgery
Patient fit for Basthi karma
Patients who are willing enroll in the study by Giving written consent  
 
ExclusionCriteria 
Details  Patients with secondary fistula like- Ulcerative colitis, Crohn’s disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal,Oesteomyelitis of ischial tuberosity
Patients with other systemic illness like uncontrolled hypertension and uncontrolled Diabetes Mellitus, HIV and HBsAg positive patients
Pregnancy and lactating women
Patients having haemoglobin less than 10 gm%
Patients with h/o impaired cardiac, renal and hepatic function.
Diagnosed as High anal fistula
Pruritus ani,boils around anal region ,folliculitis  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Unit cutting time
length of tract 		 before and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 

FOLDER
Quality OF Assessment Tool
 		 folder: before tratment
quality of life assesment: before treatment , after treatment  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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 
Date of First Enrollment (India)   10/02/2025 
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="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Most researches undertaken on ksharasutra have given good results but only focused on managing the disease. But none of them have given attention towards the Samprapthi Vighatana. So in this study we have planned to treat Apana Vayu Vaigunya with modified Basti Chikitsa followed by ksharasutra therapy in order to minimize reccurence, initiate faster wound healing and minimize usage of kshara sutra during follow up sittings. 
Close