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CTRI Number  CTRI/2024/10/074843 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A STUDY OF APAMARGA KSHARA PRATISARANA AND LORD’S ANAL DILATION IN CHRONIC FISSURE-IN-ANO. 
Scientific Title of Study   A COMPARATIVE STUDY OF APAMARGA KSHARA PRATISARANA AND LORD’S ANAL DILATION IN PARIKARTIKA W.S.R. TO CHRONIC FISSURE-IN-ANO WITH OR WITHOUT FISSURE TAG [OPEN LABEL RANDOMIZED 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  Keyoor Chetanbhai Dave 
Designation  MS scholar 2nd year 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Post graduate department of Shalya tantra, Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At p.o. Saji, Kalol, Gandhinagar

Gandhinagar
GUJARAT
382725
India 
Phone  9723955860  
Fax    
Email  dkeyoor300@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Darshana Ramole 
Designation  Professor  
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Post graduate department of Shalya tantra, Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At p.o. Saji, Kalol, Gandhinagar

Gandhinagar
GUJARAT
382725
India 
Phone  9970728218  
Fax    
Email  drdarshna@swaminarayanuniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Keyoor Chetanbhai Dave 
Designation  MS scholar 2nd year 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Post graduate department of Shalya tantra, Shree Swaminarayan Ayurvedic College Ahmedabad-Mehsana Highway At p.o. Saji, Kalol, Gandhinagar

Gandhinagar
GUJARAT
382725
India 
Phone  9723955860  
Fax    
Email  dkeyoor300@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College and Hospital, Ahmedabad-Mehsana Highway At and Po.Saji Ta.Kalol Dist.Gandhinagar-382725 
 
Primary Sponsor  
Name  Premswarup Swami Ayurvedic Multi Speciality Hospital Kalol 
Address  Shree Swaminarayan Ayurvedic College Premswarupswami Ayurvedic multispeciality Hospital Ahmedabad-Mehsana Highway At and Po.Saji Ta.Kalol Dist.Gandhinagar-382725 
Type of Sponsor  Research institution and hospital 
 
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 
Keyoor Chetanbhai Dave  Premswarup Swami Ayurvedic Multi Speciality Hospital   ShalyaTantra Department ,Premswarupswami Ayurvedic Multispeciality Hospital Ahmedabad-Mehsana Highway At and Po.Saji Ta.Kalol
Gandhinagar
GUJARAT 		 9723955860

dkeyoor300@gmail.con 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Shree Swaminarayan Ayurvedic College and Hospital Kalol  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K601||Chronic anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Su. Su. 11, Procedure details: Local application of kshar one time at chronic fissure site until samyak kshar dagdha lakshana are seen. Followed by neutralisation with amla dravya-nimbu swaras.)
(1) Medicine Name: Apamarga Kshara, Reference: Su. Su. 11, Route: Topical, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 1 Days
2Comparator Arm (Non Ayurveda)-Lord’s Anal Dilation Four finger dilation of anal canal under suitable anaesthesia
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having fissure in ano for more than 6 weeks 
 
ExclusionCriteria 
Details  not suitable for anesthesia; contraindicated for kshara karma; structural abnormalities/malformations on rectum and anal canal; below 18 & above 60 year age; malignancy of any organ; HIV, VDRL, Hepatitis-B, and T.B.; associated with piles & fistula and papilla; multiple fissure-in-ano; uncontrolled HTN and DM 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evalute the efficacy of kshara pratisarana in the management of parikartika  Day 1,3,7,15,30 
 
Secondary Outcome  
Outcome  TimePoints 
To understand parikartika based on ayurvedic principles and to evaluate and compare efficacy of kshara pratisarana and lord’s anal dilation.  30 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/10/2024 
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 - NO
Brief Summary   I Dr. Keyoor Chetanbhai Dave, will conduct this trial to evaluate the effectiveness of kshara pratisarana in management of parikartika ( chronic fissure-in-ano); due to daily lifestyle and food habits of population, the number of patients having issues related to GI track and specially lower GI( rectum and anal canal) are trending upwards. Therefore this trial aims to compare the conventional lord’s anal dilation to Ayurvedic procedure which has been practiced for many years that is known as kshara karm. 
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