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CTRI Number  CTRI/2024/10/075665 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of non healing Wound using Dushta-Vrana Prashaman Lepa and Haridra Avachurnana  
Scientific Title of Study   Comparative Evaluation on Effect of Dushta-Vrana Prashaman Lepa and Haridra Avachurnana in Dustha-Vrana  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Kumar Gupta 
Designation  Professor 
Affiliation  Rishikul Campus ,Uttarakhand Ayurved University,Haridwar 
Address  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL

Hardwar
UTTARANCHAL
249401
India 
Phone  9412856414  
Fax    
Email  akg1409@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Kumar Gupta 
Designation  Professor 
Affiliation  Rishikul Campus ,Uttarakhand Ayurved University,Haridwar 
Address  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL

Hardwar
UTTARANCHAL
249401
India 
Phone  9412856414  
Fax    
Email  akg1409@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Richa Arya 
Designation  PG Scholar 
Affiliation  Rishikul Campus ,Uttarakhand Ayurved University,Haridwar 
Address  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL

Hardwar
UTTARANCHAL
249401
India 
Phone  7983353599  
Fax    
Email  aryaricha1000@gmail.com  
 
Source of Monetary or Material Support  
OPD No. 7, Deptt. of Shalya Tantra, Rishikul Campus, Uttarakhand Ayurved University, Haridwar uttarakhand india 249401  
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University,Railway Road, Harrawala, Dehradun Uttarakhand India 248001 
Type of Sponsor  Government 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 Richa Arya  Rishikul Campus, Haridwar  OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 249401 India Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL 		 7983353599

aryaricha1000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T813||Disruption of wound, not elsewhereclassified. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:T813||Disruption of wound, not elsewhereclassified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar Samhita, Procedure details: Local application of Dushta-Vrana Prashaman Lepa in the affected wound site. Dressing will be done with sterile bandage & will be change daily. )
2Comparator ArmProcedure-avacUrNan  , अवचूर्णन  (Procedure Reference: Sushruta Samhita, Procedure details: Haridra Avachurnana will be done locally in the affected wound site & Dressing will be change daily with sterile bandage.)
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1-Patients suffering from Dushta-Vrana on any part of the body.
2-Non specific ulcers.
3-Burn wounds
 
 
ExclusionCriteria 
Details  1-Patients with evidence of malignancy and malignant ulcers.
2-Specific ulcers (tubercular ulcers, syphilitic ulcers, etc.)
3-Traumatic wounds
4-Underlying bony lesions.
5-Patient with bleeding disorders.
6-HIV, Hepatitis B, Hepatitis C positive patient.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome will be measured with the parameters-
01.Pain
02.Itching
03.Tenderness
04.Floor/Granulation
05.Discharge
06.Size
07.Foul smell 		 It will be assessed every 15th day, Until Wound heal completely. 
 
Secondary Outcome  
Outcome  TimePoints 
Expected improvement and healing in the non healing wound of
patients by relief in the symptoms like pain ,discharges and size of the wound. 		 It will be assessed every 15th day, Until Wound heal completely. 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   28/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/10/2024 
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   Non-healing ulcers are the most common problem encountered in clinics today. Ulcer is a discontinuity over the skin exhibiting loss of epidermis, dermis, and sometimes subcutaneous fat as well. In Ayurveda, Dushta vrana can be correlated with non-healing ulcers. Acharya Susrutha detailed Dushta Vrana in Chikitsa Sthana. It is characterized by symptoms like Durgandha (foul smell), Vedana (pain), Chirakali (chronicity), Utsangi (elevated), Atipooyasrava (pus discharge), Atigandha Vrana srava, etc. All these features can be observed in non-healing ulcers. 



 
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