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CTRI Number  CTRI/2023/04/051320 [Registered on: 05/04/2023] Trial Registered Prospectively
Last Modified On: 04/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Healing effect of Panchatikta Ghrita Guggulu in Fistula in ano 
Scientific Title of Study   A comparative study of healing effect of Panchatikta ghrita guggulu and Shigru Guggulu in fistula in ano with partial fistulotomy and Ksharsutra application - A randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Praveen Kumar 
Designation  Ph.D Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalya Tantra All India Institute of Ayurveda Sarita Vihar New Delhi

East
DELHI
110076
India 
Phone  9968686823  
Fax    
Email  praveensurgeon9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Yogesh Badwe 
Designation  Professor and HOD 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalya Tantra All India Institute of Ayurveda Sarita Vihar New Delhi

East
DELHI
110076
India 
Phone  9011060498  
Fax    
Email  dryogesh.badwe@gmail.com  
 
Details of Contact Person
Public Query  
Name  Praveen Kumar 
Designation  Ph.D Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Shalya Tantra All India Institute of Ayurveda Sarita Vihar New Delhi

East
DELHI
110076
India 
Phone  9968686823  
Fax    
Email  praveensurgeon9@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri Saritavihar New Delhi 110076 
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 
Praveen Kumar  All India Institute of Ayurveda  OPD of Department of Shalya Tanta All India Institute of Ayurveda New Delhi
East
DELHI 		 9968686823

praveensurgeon9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Panchatikta Ghrita Guggulu, Reference: API, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Shigru Guggulu, Reference: API, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of Primary Fistula in ano (Cryptoglandular infection) of either gender  
 
ExclusionCriteria 
Details  1 Secondary Fistula in ano
2 Age below 18 years and above 60 years
3 Severe anaemia
4 Anorectal carcinoma
5 Osteomyelitis
6 Inflammatory bowel disease
7 Pregnancy
8 Diabetes mellitus
9 Tubercular fistula in ano
10 Hypertension
11 HIV HBsAg and HCV positive patients
12 patients who are not willing to part of study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete uneventful healing of the fistulotomy wound   First week, first month, Second month, Third month 
 
Secondary Outcome  
Outcome  TimePoints 
good scar without any hypertrophy   three months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   17/04/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
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 - Clinical Study Report
    Response (Others) -  Anyone
  3. Who will be able to view these files?
    Response (Others) -  All

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Open access

  6. For how long will this data be available start date provided 01-01-0001 and end date provided 01-01-0001?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Fistula in ano is a very difficult disease to tackle and cure. Ksharsutra therapy provides a ray of hope to the suffering humanity as it ensures minimal invasion and minimal recurrence rates. The healing after partial fistulotomy and ksharsutra application has been an issue on account of contamination in the wound. The wound healing can be augmented by using Panchtikta Ghrita Guggulu as an oral drug in these patients. The Shigru guggulu has been in use post operatively in these cases. Panchatikta ghrita guggulu is a potent drug for the use in various dermatosis and it can be studied in comparison to Shigru guggulu. The dose shall be same for both drugs and that is 500 mg twice a day for 30 days. The patients shall be selected from OPD and IPD of department of Shalya tantra, All India Institute of Ayurveda and the groups shall be allocated on random basis. Shigru Guggulu shall be the control. Statistical calculations shall be carried out in terms of mean (x), SD, SE, Z test and finally the results shall be incorporated in terms of probability (p) 
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