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CTRI Number  CTRI/2023/05/052240 [Registered on: 02/05/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to Study on the effects of two medicated threads,thuttakadi sutra and apamarga ksharasutra in bhagandara  
Scientific Title of Study   Randomized controlled trial on the efficacy of thuttakadi sutra against apamarga ksharasutra in bhagandara 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anagha U 
Designation  PG Scholar, Department of Salyatantra 
Affiliation  Government Ayurveda College Tripunithura 
Address  Government Ayurveda College,Tripunithura,Ernakulam
nil
Ernakulam
KERALA
682301
India 
Phone  08921723363  
Fax    
Email  anu.4493@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M M Abdul Shukkoor 
Designation  Professor and H.O.D 
Affiliation  Government Ayurveda College Tripunithura 
Address  Government Ayurveda College, Tripunithura, Ernakulam
nil
Ernakulam
KERALA
682301
India 
Phone  9447661001  
Fax    
Email  drsukoor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M M ABDUL SHUKKOOR 
Designation  PROFESSOR AND H.O.D 
Affiliation  Government Ayurveda College Tripunithura 
Address  Government Ayurveda College, Tripunithura,Ernakulam
nil
Ernakulam
KERALA
682301
India 
Phone  9447661001  
Fax    
Email  drsukoor@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Tripunithura Ernakulam 
 
Primary Sponsor  
Name  Government Ayurveda College Tripunithura Ernakulam 
Address  Government Ayurveda College Tripunithura,Puthiyakavu,Ernakulam682301 
Type of Sponsor  Other [Government Ayurveda College Tripunithura Ernakulam] 
 
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 
Anagha U  Government Ayurveda College Tripunithura   OP No 4, Department of Salyatantra,Government Ayurveda College Tripunithura
Ernakulam
KERALA 		 08921723363

anu.4493@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee For Ethics In Research  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: Chakradutta, Procedure details: ksharasutra changing done on every 7th day)
(1) Medicine Name: Apamarga Ksharasutra, Reference: chakradutta, Route: Rectal, Dosage Form: Kshara, Dose: 1(mg), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Chakradutta, Procedure details: After 7 days of coating of medicated thread, the medicated thread is applied to the participants, changing of medicated thread will be done on every 7th day.)
(1) Medicine Name: Thuttakadi Varti, Reference: Rasa Tarangini, Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 1(mg), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Low anal fistula diagnosed by clinical examination will be selected
2)Participants with age group of 18-60 years will be selected
3)Participants selected irrespective of gender, caste, religion and economic status
4)Participants with written consent will be selected  
 
ExclusionCriteria 
Details  Fistula in known cases of colorectal carcinoma, crohn’s, ulcerative colitis, tuberculosis
Uncontrolled diabetes mellitus, Uncontrolled hypertension.
Known case of HIV, hepatitis B or veneral diseases will be excluded 
 
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 formula (total number of days for cut through/initial length of ksharasutra (in cms)  Assessment will be done on 0th
day before applying medicated thread then weekly, prior to
change of thread changes up to 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
effect of medicated thread in pain, burning sensation, discharge, bleeding  assessment will be done on 0th day before applying medicated thread then weakly, prior to change of thread changes up to 12weeks. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 3 
Date of First Enrollment (India)   05/05/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The trial will be conducted to assess and compare the efficacy of thuttakadi sutra with apamarga ksharasutra in low anal fistula. Thuttakadi sutra will be prepared with medicines of thuttakadi varti is mentioned in Rasa tarangini. The ingredients are nirmalikrta suddha tuttha, kustha churna, triphala churna, daruharidra churna, danti-mula churna, trivrt churna, tila churna, honey, pippali churna, saindhava lavana, nimba dala swarasa. Apamarga ksharasutra will be prepared as per the procedure of making of ksharasutra described by CCRAS standardization. The study will be conducted in participants who are clinically diagnosed with low anal fistula, attending the OP and IP, Department of Salyatantra, Government Ayurveda college, Tripunithura in the age group 18 to 60 years, who satisfy the inclusion and exclusion criteria. Primary outcomes are unit cutting time  assessed by using formula.secondary outcome includes effect of pain, burning sensation, discharge which are assessed based on scale prepared by Paul O Madson and Peter and bleeding is assessed on the basis of its presence or absence. 
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