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CTRI Number  CTRI/2024/11/077397 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study on the cutting period and healing period in patient with low anal fistula, treated with apamarga ksharasutra, when the ksharasutra thread change is done at different intervals. 
Scientific Title of Study   A comparative clinical trial on the effect of cutting and healing period of apamarga kshara sutra in different intervals of kharasutra change in low anal fistula. 
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 V R 
Designation  Assistant professor  
Affiliation  Government ayurveda college, trivandrum, kerala 
Address  Department of Salyatantra Government Ayurveda College, NH 66, Vanchyoor, Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9947035121  
Fax    
Email  remyarenjith3784@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Remya V R 
Designation  Assistant professor  
Affiliation  Government ayurveda college, trivandrum, kerala 
Address  Department of Salyatantra Government Ayurveda College, NH 66, Vanchyoor, Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9947035121  
Fax    
Email  remyarenjith3784@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajith kumar 
Designation  Professor 
Affiliation  Glocal college of Ayurvedic Medical Science and Research Centre 
Address  Glocal college of Ayurvedic Medical science and Research center Mirzapur Pole, Saharanpur

Saharanpur
UTTAR PRADESH
247121
India 
Phone  8848384191  
Fax    
Email  ayudrajith@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college, Thiruvananthapuram 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Remya V R  Goverment Ayurveda College, Thiruvananthapuram  Department of shalyatantra, 3rd floor, room - sushruta hall, op room 3 Government Ayurveda Medical College and Hospital, NH66, Vanchiyoor, PIN 695001
Thiruvananthapuram
KERALA 		 9947035121

remyarenjith3784@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Government Ayurveda college,Trivandrum  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: bhaishajya ratnavali, Procedure details: Apamarga Ksharasutra applied and changing of thread done once in 7 days.)
(1) Medicine Name: Gugguluthikthakam kashayam, Reference: ashtanga hrudaya, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 3 Months
(2) Medicine Name: thriphala guggulu, Reference: sharngdhara samhita, Route: Oral, Dosage Form: Guggulu, Dose: 1(mg), Frequency: tds, Duration: 3 Months
2Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: bhaishajya ratnavali, Procedure details: Apamarga Ksharasutra applied and changing of thread done once in 3 days.)
(1) Medicine Name: Gugguluthikthakam kashayam, Reference: ashtanga hrudaya, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 3 Months
(2) Medicine Name: thriphala guggulu, Reference: sharngdhara samhita, Route: Oral, Dosage Form: Guggulu, Dose: 1(mg), Frequency: tds, Duration: 3 Months
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects who are diagnosed with low anal fistula 
 
ExclusionCriteria 
Details  Subjects who have fistula in-ano due to any other primary diseases like Chron’s disease, tuberculosis, IBS etc.

Subjects diagnosed with CA rectum, , cerebrovascular accident, rectal prolapse, rectocele, Diabetes mellitus

Subjects who are immune compromised or mal nourished

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
length of tract  on 0th, 3rd, 6th, 9th,12th,15th,18th,21st,24th 27th and30th day  
 
Secondary Outcome  
Outcome  TimePoints 
pain  on 0th, 3rd, 6th, 9th,12th,15th,18th,21st,24th 27th and30th day  
type of discharge  on 0th, 3rd, 6th, 9th,12th,15th,18th,21st,24th 27th and30th day  
Amount of discharge  on 0th, 3rd, 6th, 9th,12th,15th,18th,21st,24th 27th and30th day  
colour of granulation tissue  on 0th, 3rd, 6th, 9th,12th,15th,18th,21st,24th 27th and30th day  
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   12/12/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 - Proposals should be directed to [remyarenjith3784@gmail.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 01-11-2025?
    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   Fistula-in-ano is a common anorectal disorder treated effectively with Ksharasutra, an Ayurvedic medicated thread technique that enables simultaneous cutting, drainage, and healing of the fistulous tract, minimizing sphincter damage and incontinence. Traditionally, the thread is replaced every 7 days. This study compares the cutting and healing rates of Apamarga Ksharasutra at 3-day and 7-day replacement intervals in 74 patients with low anal fistula. Outcomes include pain, discharge, granulation tissue quality, and recurrence. 
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