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CTRI Number  CTRI/2021/04/033012 [Registered on: 22/04/2021] Trial Registered Prospectively
Last Modified On: 16/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   SMAK Therapy with Laser 
Scientific Title of Study   TREATMENT OF TRANS-SPHINCTERIC FISTULA-IN-ANO WITH COMBINED THERAPY OF LASER AND KSHARA SUTRA - A CLINICAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Amir 
Designation  M.S.(Ay) Scholar 
Affiliation  Govt.P.G. Ayurveda College and Hospital Varanasi india  
Address  Room no. 25, Shalya Tantra Dept., Govt.P.G.Ayurveda College and Hospital Varanasi india

Varanasi
UTTAR PRADESH
221002
India 
Phone  8840536935  
Fax    
Email  moamir05234@gmai.com  
 
Details of Contact Person
Scientific Query  
Name  DrArun Kumar Singh 
Designation  Lecturer 
Affiliation  Govt.P.G. Ayurveda College and Hospital Varanasi india  
Address  Room no. 25, Shalya Tantra Dept., Govt.P.G.Ayurveda College and Hospital Varanasi india

Varanasi
UTTAR PRADESH
221002
India 
Phone  9450546586  
Fax    
Email  arunsinghms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohammad Amir 
Designation  M.S.(Ay) Scholar 
Affiliation  Govt.P.G. Ayurveda College and Hospital Varanasi india  
Address  Room no. 25, Shalya Tantra Dept., Govt.P.G.Ayurveda College and Hospital Varanasi india

Varanasi
UTTAR PRADESH
221002
India 
Phone  8840536935  
Fax    
Email  moamir05234@gmai.com  
 
Source of Monetary or Material Support  
Govt.P.G.Ayurveda College and Hospital Varanasi UTTAR PRADESH India  
 
Primary Sponsor  
Name  Dept of Shalya Tantra 
Address  Govt.P.G.Ayurveda College and Hospital Varanasi UTTAR PRADESH India  
Type of Sponsor  Government medical 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 
Mohammad Amir  Shalya Tantra Dept.,Govt.P.G.Ayurveda College and Hospital Varanasi  Govt.P.G.Ayurveda College and Hospital Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH 		 8840536935

moamir05234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt.Post Graduate Ayurvedic College & Hospital,Sampurnanand Sanskrit University,Varanasi,U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LASER therapy with Kshara Sutra Application as SMAK technique  The Diode LASER (Radial Fiber) will be applied from external opening up to the level lateral to submucosa and from submucosa to the internal opening Kshara Sutra will be applied as submucosal application of Kshara Sutra (SMAK) technique the average duration is 1 to 3 months 
Intervention  Partial fistulectomy with Kshara Sutra ligation  Partial fistulectomy will be done from external opening up to the extra sphincteric level and Kshara Sutra will be applied from extra sphincteric level to the internal opening the average duration is 4 to 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Only trans-sphincteric fistula will be entertained.
Patient of Bhagandar those medically fit for surgery irrespective of
Patient either sex, occupation and religion will be included randomly.
Patient suffering from Bhagandar will be taken.
Age of patient 18-60 years will be included.
Simple anal fistula with palpable induration. 
 
ExclusionCriteria 
Details  High anal fistula.
Branched trans-sphincteric fistula.
Supralevator fistula.
Subcutaneous fistula.
Fistula other than trans sphincteric fistula.
Fistula other than ano rectal region.
Tuberculosis.
Osteomyelitis.
Chronic or Acute Ulcerative colitis.
Crohn’s disease.
Any malignancy.
Venereal disease, HIV and HBsAg positive cases.
Pregnancy.
Fistula other than ano rectal region.
Age less than 18 years and more than 60 years.
Rectal prolapse.
Complex fistula.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Treatment of BHAGANDAR  8week 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment of BHAGANDAR  4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/04/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 "SIMLIFIED TREATMENT FOR DIVERSIFIED FISTULA IN ANO"REVIEW ARTICLE,WORLD JOURNAL OF PHARMACEUTICAL RESEARCH,VOLUME 10,ISSUE 8,1354-1361,ISSN 2277-7105 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 60 Patients are registered and divided into two groups. Each group consist of 30 patients but in 2 patients from group A and 1 patient from group B are dropped out so all data given in 57 patients only  . Group A- conventional Kshara Sutra ligation. Group B- LASER therapy with Kshara Sutra Application as SMAK technique.
In group A- conventional kshara sutra ligation will be done from external opening to internal opening by probing. In group B- The Diode LASER (Radial Fiber) ablation done from external opening up to the level lateral to submucosa and from submucosa to the internal opening Kshara Sutra will be applied as submucosal application of Kshara Sutra (SMAK) technique. 
 Then to enhance the healing of wound by the application of hot sitz bath, proper cleaning of wound with sterile gauze.adjuvent therapy includes haritaki churna 5gm H.S
above study clinically assest on pain,itching,and discharge.it showed that after four follow up group A showed  82.63%relief in pain,92.02%in itching,81.82% in discharge while Group B showed 100% result in pain,itching,discharge and P value showed <0.001 which is highly significant but if analyse the full course of complete remission of fistula -Group B(trial group) showed complete remission at 42th day and Group A(controlled group) showed at 63th day.
Chi-squre,wicoxom(Z) and ,independent test applied for statistical analysis.
conclusion was that treatment given in both group are highly significant but trial group showed better result in terms of less pain,itching and discharge,less hospital visits,less discomfort,early returned to the normal life.
 
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