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CTRI Number  CTRI/2025/01/079480 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Durwadi Ghrit in the treatment of Dushta Vrana or wound 
Scientific Title of Study   To see the efficacy of Durwadi Ghrit in the management of Dushta Vrana (infected wound) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kanaklata misra 
Designation  P G Scholar 
Affiliation  S. G. M. P. G. Ayurvedic college and hospital 
Address  Department of Shalya tantra S. G. M. .P G. Ayurvedic college and hospital Saheri Ghazipur

Ghazipur
UTTAR PRADESH
233302
India 
Phone  9458514700  
Fax    
Email  kanakmishra9030@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surendra Kumar Mishra 
Designation  Professor 
Affiliation  S. G. M. P. G. Ayurvedic college and hospital 
Address  Head of Department Shalya tantra Room no 103 S. G. M. .P G. Ayurvedic college and hospital Saheri Ghazipur

Ghazipur
UTTAR PRADESH
233302
India 
Phone  9458514700  
Fax    
Email  indrajeetszmgzp@gmail.com  
 
Details of Contact Person
Public Query  
Name  kanaklata misra 
Designation  P G Scholar 
Affiliation  S. G. M. P. G. Ayurvedic college and hospital 
Address  Department of Shalya tantra S. G. M. .P G. Ayurvedic college and hospital Saheri Ghazipur

Ghazipur
UTTAR PRADESH
233302
India 
Phone  9458514700  
Fax    
Email  kanakmishra9030@gmail.com  
 
Source of Monetary or Material Support  
S G M P G Ayurvedic College and Hospital Saheri, Ghazipur, Uttar Pradesh 233302 
 
Primary Sponsor  
Name  Dr Kanak Lata Mishra 
Address  Department of Shalya Tantra S. G. M. P. G. Ayurvedic college and hospital Saheri Ghazipur 
Type of Sponsor  Other [SELF] 
 
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 
Kanaklata Misra  S. G. M. P. G. Ayurvedic College and Hospital  Department of shalya tantra, Room no 103
Ghazipur
UTTAR PRADESH 		 9458514700

kanakmishra9030@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC S.G.M.P.G. Ayurvedic College Saheri Ghazipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L02||Cutaneous abscess, furuncle and carbuncle. Ayurveda Condition: Dusta, (2) ICD-10 Condition:L029||Cutaneous abscess, furuncle and carbuncle, unspecified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Durwadi Ghrita, Reference: Bhaishajya Ratnawali Vranashothadhikar, Shlok-78, Route: Topical, Dosage Form: Ghrita, Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -nil
2Comparator Arm (Non Ayurveda)-Povidone-IodineDose as Required BID Duration 1 month
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Post surgical wound infection
2. Traumatic infected wound
3. Diabetic wound
4. Infected wound 
 
ExclusionCriteria 
Details  • Malignant ulcer
• Tubercular ulcer
• Syphilitic ulcer
• Leprotic ulcer
• Actinomyecetes
• HIV (+) patient’s wound
• HBsAg(+) patients wound
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Finally the treatment will be assessed on assessment criteria of Dusta vrana Criteria for assessing clinical features
Score Pain Discharge Slough tissue
0 No pain Nodischarge/dry dressing No slough tissue
1 Localized feeling of pain during movement only but no feeling during rest Scanty occasional discharge & little wet dressing Up to 25% area covered with slough
2 Localized feeling of pain even during rest but not disturbing the sleep Often discharge & with blood on dressing 26 to 50% area covered with slough
3 Localized continuous feeling of pain, radiating & not relieved by rest Profuse, continuous discharge which needs frequent dressing More than 50% area covered with slough
 		 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
This includes mainly size measurements, photography, and tracing. These are performed on weekly basis to estimate baseline wound status, recovery size measurements, validate overall treatment plan and to demonstrate short term response to treatment plan  1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   10/02/2025 
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 Yet Recruiting 
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 whole research work will be summarized  on the basis of the observation which will be done on the subjective and objective parameters. 

 
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