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CTRI Number  CTRI/2024/10/075233 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
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   A Clinical Trial To Study Guggulu Based Palash Ksharsutra In The Treatment Of Bhagandara. 
Scientific Title of Study   Clinical Study Of Efficacy Of Guggulu Based Palash Ksharsutra Ligation In The Management Of Bhagandara With Special Refference To Low Level 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. Rupesh Madhav Gavit 
Designation  Pg Scholar 
Affiliation  Government Ayurved College Nanded. 
Address  Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded.
Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded.
Nanded
MAHARASHTRA
431601
India 
Phone  7391032673  
Fax    
Email  rupeshgavit30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R H Amilkanthwar 
Designation  Associate Professor 
Affiliation  Government Ayurved College Nanded . 
Address  Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded.
Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded.
Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R H Amilkanthwar 
Designation  Associate Professor 
Affiliation  Government Ayurved College Nanded ,Maharashtra. 
Address  Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded.
Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded.
Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College Nanded ,Maharashtra, 431601 India. 
 
Primary Sponsor  
Name  Dr Rupesh Madhav Gavit 
Address  Government Ayurved College Nanded ,Maharashtra, 431601 India. Department Of Shalyatantra Ayurved College Nanded. 
Type of Sponsor  Other [Self sponser] 
 
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 Rupesh Madhav Gavit  Government Ayurved College And Hospital Nanded.  Department Of Shalyatantra Government Ayurved College Vazirabad,Nanded. Maharashtra.
Nanded
MAHARASHTRA 		 7391032673

rupeshgavit30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Government Ayurved College,Nanded.  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-guggulu based palash ksharsutra ligation in bhagandara (Procedure Reference: Suhruta Samhita, Cikitsasthana-17/26-30 Astang Hridya-30/35 Chakradatta, Arsha Cikitsa-148 Ras Tarangini, 24 trang 527-530 Ras Kamdehnu, Arsha chikitsa 126-128, Procedure details: Ksharsutra will be introduced into fistulous tract & will be changed on every 7th day till the cut-through of the tract)
2Comparator ArmProcedure-apamarga ksharsutra ligation in bhagandara (Procedure Reference: Suhruta Samhita, Cikitsasthana-17/26-30 Astang Hridya-30/35 Chakradatta, Arsha Cikitsa-148 Ras Tarangini, 24 trang 527-530 Ras Kamdehnu, Arsha chikitsa 126-128, Procedure details: this Ksharsutra will be introduced into fistulous tract & will be changed on every 7th day till the cut through of the tract)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient of either sex will be selected randomly for the study.
2. Patient of age group between 18 – 70 years.
3. All clinically diagnosed cases of fistula in ano
4. New or recurrent cases.
5. Low level fistula in ano. 
 
ExclusionCriteria 
Details  1. Carcinoma of rectum.
2. Pregnancy.
3. Patient suffering from any systemic disease e.g. TB, DM, CVS, HIV +ve , any acute
systemic illness.
4. Bleeding disorder
5. Patients with Multiple fistula
6. High level fistula in ano .
7. Fistula in ano secondary to ulcerative colitis or crohns disease.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Guggulu Based Palash ksharsutra ligation In the Bhagandara with
special reference to low level Fistula In Ano. 		 CUTTING OF FISTULOUS TRACT
0.5CM IN A WEEK-- WEAK KSHAR
0.75 CM IN A WEEK- MODERATE KSHAR SUTRA
1CM IN A WEEK- STRONG KSHAR SUTRA
1.5CM IN A WEEK- VERY STRONG KSHAR SUTRA   
 
Secondary Outcome  
Outcome  TimePoints 
• To find out cutting rate and healing effect of Guggulu Based Palash ksharsutra ligation
in the fistulous track.
• To find out its effect on pain and discharge of fistula. 		  1.Cured 91-100% relif in signs and symptoms
2. marked improvement 76-90%
3.Moderately improvement 51-75%
4. Mild improvement 26-50%
5. Unchanged no improvement- less than or equal to 25% releif.  
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rupeshgavit30@gmail.com].

  6. For how long will this data be available start date provided 10-10-2024 and end date provided 10-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary    This study is Prospective, Open labeled, Randomized, Controlled and Clinical study. To evaluate the efficacy of Guggulu Based Palash ksharsutra ligation In the management of Bhagandara with special reference to low anal Fistula In Ano.
Group A 36 patients who will be treated with Guggulu based palash ksharsutra 
Group B 36 patients who will be treated with snuhi apamarga ksharsutra
when applied as per requirment to the age group 18 year to 70 year once in a week. follow up on 7th,14th,21st,28th,35th,42th,49th,56th day. This study will be carried out in 2 years of pg course.
 
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