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CTRI Number  CTRI/2024/10/074895 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Controlled clinical trial to compare the efficacy of external use of Panchavalkala Ghee with betadine ointment in the management of post operative abcess 
Scientific Title of Study   Randomised controlled clinical trial to compare the efficacy of external use of Panchavalkala siddha ghrita with betadine ointment in the management of vidradhi Bhedan pashchat vrana. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Buddhiraj Satish Tupare 
Designation  MS Scholar Shalyatantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  9403465149  
Fax    
Email  buddhistupare2297@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nandkishor V Borse 
Designation  Professor & HOD Shalyatantra Department 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  9422032696  
Fax    
Email  drnvborse@gmail.com  
 
Details of Contact Person
Public Query  
Name  Buddhiraj Satish Tupare 
Designation  MS Scholar Shalyatantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  9403465149  
Fax    
Email  buddhistupare2297@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011, Maharashtra, India.  
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune 411011 
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 Buddhiraj Satish Tupare  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Department of Shalyatantra 2nd floor, Tilak Ayurved Mahavidyalaya 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA 		 9403465149

buddhistupare2297@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical committe, TAMV pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B99-B99||Other infectious diseases. Ayurveda Condition: VIDRADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Bhavprakash 46/26, Procedure details: For 3 to 5 days after I & D: Dressing with NS & H2O2 for cleaning of wound as a anti-infective. After seeing the symptoms (lakshana) of healing wound (Ruhyaman vran) instead of anti-infective agent healing agent like Panchavalkala Siddha Ghrita or Betadine ointment will be used)
(1) Medicine Name: Panchvalkala Siddha Ghrut, Reference: Bhavprakash 46/26, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 2 Weeks
2Comparator Arm (Non Ayurveda)-Betadine ointmentBetadine is an antiseptic that works by releasing iodine, which kills microorganisms that cause infection. Betadine active ingredient is iodine, a complex of iodine and povidone. Povidone improves the solubility and stability of iodine, making it more effective.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with minor (dimensions, length: 1cm-6cm, depth: up to 1cm)
and clean freshuninfected wound irrespective of age, sex, religion and socioeconomic class.
Post op incised & drained wound. 
 
ExclusionCriteria 
Details  HBsAg and HIV positive subjects, D.M., Tuberculosis and Leprosy patients.
Cases of orthopedic operatives, MRM, etc. and other major surgeries.
More than 6cm size of wound 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in size, pain, vranoshtha, redness.  7days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in size, pain, vranoshtha, redness, granulation tissue and tenderness  15 days 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   23/10/2024 
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="6"
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 - NO
Brief Summary   The study will be intervened by the treatment of Panchvalkala siddha Ghrita and Betadine ointment to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. 
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