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CTRI Number  CTRI/2024/10/075778 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To know the effect of gunja kshara sutra with apamarga kshara sutra in the management of fistula 
Scientific Title of Study   A randomized controlled clinical Study to evaluate the efficacy of Gunja Ksharasutra with Apamarga Ksharasutra in the patients of Bhagandhara(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  Dudekula Shareef 
Designation  Post graduate scholar 
Affiliation  S.V Ayurvedic College and Hospital 
Address  Department of Shalya Tantra, S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh, pin 517501.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9490294810  
Fax    
Email  shareefdudekula2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K V Vijaya Bhaskara Reddy 
Designation  PROFESSOR AND HOD 
Affiliation  S.V Ayurvedic College and Hospital 
Address  Department of Shalya Tantra, S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh, pin 517501.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9849451333  
Fax    
Email  drkvbreddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dudekula Shareef 
Designation  Post Graduate Scholar 
Affiliation  S.V Ayurvedic College and Hospital 
Address  Department of Shalya Tantra, S.V Ayurvedic College and Hospital, Tirupati, Chittoor, Andhra Pradesh, pin 517501.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9490294810  
Fax    
Email  shareefdudekula2010@gmail.com  
 
Source of Monetary or Material Support  
S.V Ayurvedic College and Hospital 
 
Primary Sponsor  
Name  S.V Ayurvedic College and Hospital 
Address  Near SVIMS campus, Tirupati, Chittoor, Andhra Pradesh, pin 517501 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Shareef  S.V Ayurvedic college and Hospital  Department of Shalya Tantra, Op no.5,Near SVIMS campus, Tirupati, Chittoor, AP 517501
Chittoor
ANDHRA PRADESH 
9490294810

shareefdudekula2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of TTDs S.V. Ayurvedic College  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
1Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Charaka Chikitsa12/96-97, Susruta chikitsa 17/32, Procedure details: Procedure details: The study will be carried out in three phases. Phase 1: Preparation of Gunja Kshara Sutra, Preparation of specific record sheets. Identification of cases, diagnosis, scrutinizing, registration & grouping. Phase 2: Application of Kshara Sutra under Local Anesthesia by probing from external opening & taking out of probe from internal opening by applying kshara sutra.Change of Kshara Sutra will be done every week by railroad technique till the complete cut open of the tract. Phase 3: Healing of the whole tract. Follow up after the complete healing for 2 months with 15 days intervals. Evaluation, documentation, & statistical unPaired t-test & p-values to check level of significance.)
2Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Charaka Chikitsa12/96-97, Susruta chikitsa 17/32, Procedure details: Procedure details: The study will be carried out in three phases. Phase 1: Preparation of Apamarga Kshara Sutra. Preparation of specific record sheets. Identification of cases, diagnosis, scrutinizing, registration & grouping. Phase 2: Application of Kshara Sutra under Local Anesthesia & applying the Kshara sutra by probing from external opening & taking out of probe from internal opening by applting ksharasutra. Change of Kshara Sutra will be done every week by rail raod technique till the complete cut open of the tract. Phase 3: Healing of the whole tract. Follow up after the complete healing for 2 months with 15 days intervals. Evaluation, documentation & statistical unPaired t-test & p-values to check level of significance. )
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients irrespective of Gender and religion from
the age group of 20 to 60 years.
2. Patients Patients with signs and symptoms of
Bhagandhara.
3. Patients who are diagnosed as Fistula-in-ano. 
 
ExclusionCriteria 
Details  1. Concomitant Ano-rectal conditions like
ulcerative colitis, malignancy, Crohn’s
disease, multiple fistulae.
2. Pregnancy.
3. Tuberculosis.
4. Obstructive Uropathies.
• Systemic diseases like CAD, Portal hypertension.
• Patients with controlled blood sugars. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Accessing the pain, discharge, itching, unit cutting time and tenderness for every week until cut open of a track. The efficacy is calculated by comparing the both subjecive and objective parameters of both ksharasutras each other.
 
Once a week, following the replacement of an existing ksharasutra, until the entire track is cut open.

 
 
Secondary Outcome  
Outcome  TimePoints 
Complete healing time, reoccurrences & any other complications like incontinency, discharge, etc.  After the entire track is cut open, follow up with a patient for 2 months with an interval of 15 days. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   02/11/2024 
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="6"
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  

         Bhagandhara can be compared with Fistula-in-ano in terms of clinical features and treatment. The word fistula is derived from the Latin word a Reed, pipe, or flute. It implies a chronic granulating Track connecting two epithelial-lined surfaces. These Surfaces may be cutaneous or mucosal. The main Cause known for fistula-in-ano is a crypto glandular Infection of anal crypts. The anal fistula is a single Track with an external opening in the skin of the peri- Anal region and an internal opening in the modified Skin or mucosa of the anal canal or rectum. Various operative procedures often lead to complications like recurrence, Anal incontinence, infections, etc. The prevalence rate is 8.6 cases per 1000 population. The male-to-female ratio is about 1.8:1. It is categorized as a surgical domain which still to date is where surgeons have been struggling for centuries with its incurable with recurrence rate of 30%-40%.

          Acharya Sushruta described Bhaishajya chikitsa, Kshara karma, Agni Karma, and Shastra Karma chikitsa for anorectal Diseases. Kshara karma comes under anusastra which is defined as hina sastra (sub-surgical condition) or shaly sadrusya(similar to a surgical instrument), used like a surgical instruments but with lesser invasion and stress on the patients. Bhagandara is a Chedya (excision) vyadhi. The Ksharasutra is a Para-surgical measure capable to perform excision slowly by virtue of its mechanical pressure and chemical action in Bhagandara because the kshara possesses the qualities of chedana, bhedana, lekana, and tridoshahara.

       kshara sutra is mentioned in the textual references of Chakradatta and Rasatarangini where we get only indication of a thread made up of snuhi, apamarga and haridra. Acharya Susrutha mentioned 23 types of plants useful for kshara karma (sus. su 11/11) like gunja, palasha, kutaja, and Gunja14.

 Need for the study:

     Kshara sutra is a successful novel drug delivery system in managing the cases of fistula-in ano but it has certain clinical problems like Pain, Burning sensation, Inflammation, duration for the complete cutting of the track anf finally complete healing time.

Scope of the study:

  Gunja has tridoshahara properties which will works on all the doshas and helps to minimize adverse effects like inflammation, itching, burning sensation, pain and thereby decreases uct (unit cutting time) followed by fast healing of the wound. Gunja plant available in all seasons, it can be cultivated easily and economically. This study helps to develop a alternate standard Gunja kshara sutra along with Apamarga kshara sutra. 

 
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