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CTRI Number  CTRI/2026/03/106027 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 06/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the effects of two Ksharasutras, Arka Ksheera based Tankana Ksharasutra and Apamarga Ksharasutra in patients with anal fistula. 
Scientific Title of Study   Efficacy of Arka Ksheera–based Tankana Ksharasutra against Apamarga Ksharasutra along with standard treatment in Low Anal Fistula: A Randomised Controlled Trial 
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 Remya VR 
Designation  Associate Professor  
Affiliation  Government Ayurveda College Thiruvananthapuram  
Address  Department of Shalyatantra Government Ayurveda College Thiruvananthapuram, Kerala 695001, India

Thiruvananthapuram
KERALA
695001
India 
Phone  9947035121  
Fax    
Email  remyarenjith3784@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Remya VR 
Designation  Associate Professor  
Affiliation  Government Ayurveda College Thiruvananthapuram  
Address  Department of Shalyatantra Government Ayurveda College Thiruvananthapuram, Kerala 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  9947035121  
Fax    
Email  remyarenjith3784@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nayana S Nair  
Designation  Pg Scholar  
Affiliation  Government Ayurveda College Thiruvananthapuram  
Address  Department of Shalyatantra Government Ayurveda College Thiruvananthapuram, Kerala 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  7012238869  
Fax    
Email  nayans939@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Government Ayurveda College Thiruvananthapuram  
Address  Government Ayurveda College Thiruvananthapuram Kerala 695001 India  
Type of Sponsor  Other [Government Ayurveda College ] 
 
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 
DrNayana S Nair  Government Ayurveda Collge Thiruvanathapuram  Department of Shalyatantra Government Ayurveda College Thiruvanathapuram 695001 Kerala
Thiruvananthapuram
KERALA 		 7012238869

nayans939@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (IEC) GOVT AYURVEDA COLLEGE   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 zारसूm (Procedure Reference: Susruta Samhitha Chikitsa Sthana 17/29-32, Procedure details: The participant will be comfortably laid in the lithotomy position. Local anaesthesia will be performed by injecting lignocaine hydrochloride 2% until the patient is properly anesthetized A malleable copper probe will be introduced into the external opening & it will be carefully introduced along the tract. The finger kept in the anal canal will support the movement of the probe towards the internal opening. The probe will be brought out of the internal opening and then it will be carefully taken out through the anal canal. Apamarga Ksharasutra of suitable length will be passed through the eye of the probe and the probe will be pulled out, to position the thread in the tract. The two ends of the thread will be tied outside the anal orifice. Sterile pad will be applied to the area. )
(1) Medicine Name: Apamarga Ksharasutra, Reference: Susruta Samhitha Chikitsa Sthana 17/29-32, Route: Rectal, Dosage Form: Kshara, Dose: 5(g), Frequency: od, Duration: 8 Weeks
2Intervention ArmProcedure-kShArasUtra zारसूm (Procedure Reference: Rasakamadhenu Arshasam roganidanachikitsa, Rasatarangini Taranga 14, Procedure details: The participant will be comfortably laid in the lithotomy position. Local anaesthesia will be performed by injecting lignocaine hydrochloride 2% until the patient is properly anesthetized A malleable copper probe will be introduced into the external opening & it will be carefully introduced along the tract. The finger kept in the anal canal will support the movement of the probe towards the internal opening. The probe will be brought out of the internal opening and then it will be carefully taken out through the anal canal. Arka Ksheera based Tankana Ksharasutra of suitable length will be passed through the eye of the probe and the probe will be pulled out, to position the thread in the tract. The two ends of the thread will be tied outside the anal orifice. Sterile pad will be applied to the area. )
(1) Medicine Name: Arka Ksheera based Tankana Ksharasutra, Reference: Rasakamadhenu Arshasam roganidanachikitsa, Rasatarangini Taranga 14, Route: Rectal, Dosage Form: Kshara, Dose: 5(g), Frequency: od, Duration: 8 Weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of Low Anal Fistula
 
 
ExclusionCriteria 
Details  Known cases of colorectal carcinoma, Crohns disease, ulcerative colitis, and tuberculosis.

Known cases of uncontrolled diabetes mellitus, uncontrolled hypertension, HIV, hepatitis B, and venereal diseases. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Unit Cutting Time of the Ksharasutra measured by the formaula Total number of days for cut through /Initial length of Ksharasutra   Assessment of Unit Cutting Time will be done on 0th day (after Ksharasutra application),7thday(first week),2nd week,3rd week, 4th week, 5th week, 6th week, 7th week, 8th week or till complete cut through of tract 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of Ksharasutra in pain assessed by the VAS scale & discharge assessed by the Paul O Madson & Peter grading.  Assessment will be done on 0th day & every seventh day after Ksharasutra application till eight weeks or up to complete cut-through of the tract. 
 
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)   27/03/2026 
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="6"
Days="0" 
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   Present study is a Randomised controlled trial which has been undertaken to evaluate efficacy of Arka Ksheera based Tankana Ksharasutra in the management of  Low Anal Fistula and to compare its efficacy with Apamarga Ksharasutra along with standard treatment .50 Participants clinically diagnosed with Low Anal Fistula will be selected from OPD and IPD of Shalyatantra department, of Government Ayurveda College hospital Thiruvananthapuram satisfying both inclusion and exclusion criteria. Block  Randomisation with allocation concealment using sequentially numbered opaque sealed envelopes will be done with the help of a faculty / statistician who is not directly involved in the study. Participants will be blinded. Trial group will receive Arkaksheera based Tankana Ksharasutra while the control group will receive Apamarga Kshara sutra. Changing of Ksharasutra will be done on every 7th day upto eight weeks or till complete cutting through the tract .Assessment will be conducted based on both objective and subjective parameters including UCT, pain and discharge, on every 7 th day. Collected data will be statistically analyzed and the study will be concluded. 
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