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CTRI Number  CTRI/2024/10/074658 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 02/10/2024
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   Clinical Trial Proposal : Efficacy of Madhu based Tankana Ksharasutra vs.Snuhi based Apamarga Ksharasutra in Patients with Bhagandhara (Fistula in ano) 
Scientific Title of Study   Comparative clinical study on the effect of madhu based tankana ksharasutra and standard apamarga ksharasutra in bhagandara( fistula in ano) 
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 Ancitta Jose 
Designation  Pg Scholar- Department of Shalya Tantra 
Affiliation  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  SDM College of Ayurveda and Hospital Hassan
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India 
Phone  9496936056  
Fax    
Email  ancittajose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mahesh Kumar E S 
Designation  Associate Professor - Department of Shalya Tantra 
Affiliation  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  SDM College of Ayurveda and Hospital Hassan
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India 
Phone  8073851473  
Fax    
Email  drmaheshkumar@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  Dr Mahesh Kumar E S 
Designation  Associate Professor - Department of Shalya Tantra 
Affiliation  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India 
Phone  8073851473  
Fax    
Email  drmaheshkumar@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan-573201 Karnataka India 
 
Primary Sponsor  
Name  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan-573201 India 
Type of Sponsor  Private 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 
Dr Mahesh Kumar E S  Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan  OPD number 11 Department of Shalya Tantra Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA 
8073851473

drmaheshkumar@sdmcahhassan.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K605||Anorectal fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Madhu based Tankana Ksharasutra   First the patient will be kept in lithotomy position after Local/Spinal anaesthesia perianal region will be cleaned with antiseptic lotions and draped. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of fistula. The tip of the probe will be forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip will be finally directed to come out of anal orifice. Then a suitable length of Madhu based Tankana Kshara Sutra will be taken and threaded into the eye of probe. Thereafter the probe will be pulled out through the anal orifice, to leave the thread behind in the fistulous track. The two ends of the thread will be then tied together with a moderate tightness outside the anal canal 
Comparator Agent  Standard Apamarga Ksharasutra  First the patient will be kept in lithotomy position after local/spinal anaesthesia perianal region will be cleaned with antiseptic lotions and draped. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of fistula. The tip of the probe will be forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and its tip will be finally directed to come out of anal orifice. Then a suitable length of Madhu based Apamarga Kshara Sutra will be taken and threaded into the eye of probe. Thereafter the probe will be pulled out through the anal orifice, to leave the thread behind in the fistulous track. The two ends of the thread will be then tied together with a moderate tightness outside the anal canal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinical signs and symptoms of all types of Bhagandara
2.Recurrent Fistula- in-ano
3.Patients who give written surgical consent
4.Patients fit for surgery
5.Patients above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status.
 
 
ExclusionCriteria 
Details  1.Patients with secondary fistula due to Ulcerative colitis, Crohns disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal
2.Patients with Retro and HBsAg positive
3.Pregnancy and lactating women
4.Patients with impaired cardiac, renal and hepatic function.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Unit Cutting Time of Fistulous Track  assessment will be done at baseline, followed by weekly assessment until the fistula tract is completly healed 
 
Secondary Outcome  
Outcome  TimePoints 
Pain
Discharge
Granulation tissue
Size of wound 
will be assessed baseline, followed by weekly follow up every week until the fistula tract heals 
 
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 3 
Date of First Enrollment (India)   13/10/2024 
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="1"
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  

Bhagandara is second common disease occurring in ano-rectal region after haemorrhoids. The word Fistula is derived from a Latin word reed, pipe or flute. It implies a chronic granulation track connecting two epithelial lined surfaces. The prevalence rate of fistula-in-ano is 8.6 cases per 1 lakh population. The prevalence in men is 12.3 and in women is 5.6 cases per 1 lakh population. The male-to-female ratio is 1.8:1. The mean age of patients is 38.3 years. It is considered as one among the Mahagada in Sushruta Samhita. In Ayurveda Ksharasutra application is well known for management of Bhagandara.

Though in this disease many Ksharasutras tried, Apamarga Ksharasutra is widely being practiced.  When go through the classics we get reference regarding  Tankana grouped into Kshara Dravyas. This Tankana is not widely practiced. Apamarga is very effective but preparation of this Apamarga  Kshara is not at all easy process. It needs burning of lots of Apamarga plants,then processing including boiling etc, and the end we get a little quantity of final product. In other hand Tankana, as per reference, is also a Kshara, cost effective and abundantly available. It minimizing the problems like burning sensation, local irritation during the course of therapy.

Madhu has Vranaropaka properties as per the principles of the sixty Upakramas of Vrana management described in Susrutha Samhitha . The authors like Chakrapani, Susruta, Bhavaprakasha, Vangasena and Yogaratnakara have described the qualities of Madhu as Vranashodhana, Vranaropana, Lekhana, Sandhana, Varnya, Srotovishodana, Yogavahi..                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         

Advantages of Kshara Sutra Therapy: Simple and safe parasurgical procedure, cost-effective and ambulatory, minimal recurrence rate, no surgical complications like incontinence, stenosis and stricture. Snuhi Ksheera based Apamarga ksharasutra is the standard one and is proved effective treatment in the management of Fistula-in-ano. But, burning sensation, local irritation during the course of therapy and difficulty of manufacturing process has limited its use.

To overcome these problems, I have taken the study of  Madhu based Tankana Kshara sutra for better action, availability and acceptability. Madhu based Tankana Kshara sutra will be prepared by the same method as that of Snuhi Apamarga Kshara Sutra. So, the present study has been taken up to know the efficacy of Madhu based Tankana Kshara Sutra in the management of Bhagandhara.

 

 
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