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CTRI Number  CTRI/2023/11/059793 [Registered on: 14/11/2023] Trial Registered Prospectively
Last Modified On: 09/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized Factorial Trial 
Public Title of Study   To study the effect of Priyangwadi ointment with compare to Silver colloid ointment for the treatment of post operative Incision & drainage wound. 
Scientific Title of Study   “RANDOMISED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF EXTERNAL USE OF PRIYANGWADI OINTMENT WITH SILVER COLLOID OINTMENT IN THE MANAGEMENT OF VIDRADHI BHEDAN PASHCHAT VRAN" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Durga Sanjay Gaikwad  
Designation  Pg Scholar shalyatantra 
Affiliation  Tilak Ayurveda Mahavidyalay 
Address  Dept Of Shalyatantra,Tilak Ayurved Mahavidyalaya Pune
Rasta peth,Pune
Pune
MAHARASHTRA
411011
India 
Phone  7040806520  
Fax    
Email  apoorvagaikwad2513@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhanraj Bhagwan Gaikwad  
Designation  Associate professor, Shalyatantra dept. 
Affiliation  Tilak ayurved mahavidyalaya  
Address  Dept Of Shalyatantra,Tilak Ayurved Mahavidyalaya Pune

Pune
MAHARASHTRA
411011
India 
Phone  9422342048  
Fax    
Email  Draj.gaikwad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dhanraj Bhagwan Gaikwad  
Designation  Associate professor , Shalyatantra dept. 
Affiliation  Tilak Ayurveda Mahavidyalay, Pune. 
Address  Dept Of Shalyatantra,Tilak Ayurved Mahavidyalaya Pune

Pune
MAHARASHTRA
411011
India 
Phone  9422342048  
Fax    
Email  Draj.gaikwad@gmail.com  
 
Source of Monetary or Material Support  
Tilak Ayurved Mahavidyalaya Pune 
 
Primary Sponsor  
Name  Tilak Ayurved Mahavidyalaya Pune 
Address  Rastapeth pune 11 
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 
Dr Durga Sanjay Gaikwad   SETH TARACHAND RAMNATH CHARITABLE AYURVED HOSPITAL  OPD NO.7, DEPARTMENT OF SURGERY Pune MAHARASHTRA
Pune
MAHARASHTRA 		 7040806520

apoorvagaikwad2513@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital, Rastapeth pune 11  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L029||Cutaneous abscess, furuncle and carbuncle, unspecified. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Priyangwadi ointment , Reference: Sushrut chikitsa 16/43, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Megaheal ointmentSilver colloid ointment ;Local application;1g ; once daily; 2 weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Post operated incised & drained wound of maximum size 1cm to 6cm & depth 6cm 
 
ExclusionCriteria 
Details  Patient with tuberculosis, leprosy, HIV & HBsAg and metabolic disorders and infected wound. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Healthy healing wound with reducing the size of wound.
With pain(shula), redness (Araktata), edges(vrana oshtha), granulation, tenderness (sparshasahatwa) 		 Baseline 11th day 
 
Secondary Outcome  
Outcome  TimePoints 
Healthy healing wound with reducing the size of wound.
With pain(shula), redness (Araktata), edges(vrana oshtha), granulation, tenderness (sparshasahatwa) 		 2 to 3 weeks 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   20/11/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   As I have observed in case of abscess patients after I & D a deep wound is formed. This takes long duration for its healing as it has to heal by secondary healing from its base. In such wounds patient need prolonged hospitalization for neat dressing from skilled person which otherwise would complicate the wound or causes recurrence.
In modern science many local ointments, gels etc. are available which enhance secondary healing of abscess wound from base for example megaheal ointment (content - Silver colloid). This I thought of similar kind of Ayurvedic alternative drug which will enhance faster wound healing as well as which will be side effects free. As a result I have choosen ’Priyangwadi ointment’ as my topic of dissertation.
 
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