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CTRI Number  CTRI/2026/02/104781 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Drug Trial On Chronic Wounds 
Scientific Title of Study   Clinical Evaluation Of The Advanced Dressing Material Impregnated With Kshara Of Butea Monosperma And Taila Of Cynodon Dactylon In The Management Of Dushtavrana (Chronic Wound) - A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankit Sarraf 
Designation  Junior Resident 
Affiliation  IMS , BHU 
Address  Department Of Shalya Tantra, Faculty of Ayurveda,IMS,BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8871502227  
Fax    
Email  ankitsarraf36@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Gupta 
Designation  Associate Professor 
Affiliation  IMS, BHU 
Address  Department Of Shalya Tantra, Faculty of Ayurveda,IMS,BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9532852272  
Fax    
Email  rashmi.gupta@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Rashmi Gupta 
Designation  Associate Professor 
Affiliation  IMS, BHU 
Address  Department Of Shalya Tantra, Faculty of Ayurveda,IMS,BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9532852272  
Fax    
Email  rashmi.gupta@bhu.ac.in  
 
Source of Monetary or Material Support  
Sir Sunderlal Hospital, Faculty of Ayurveda, IMS, BHU, Varanasi (U.P.) 221005 INDIA 
 
Primary Sponsor  
Name  Department of Shalya Tantra Institute of Medical Sciences 
Address  Faculty of Ayurveda,Institute of medical sciences,Banaras Hindu University Varanasi 221005 India 
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 Ankit Sarraf  Sir Sunderlal Hospital, Banaras Hindu University  Opd No. 12,14,16A & NRC, Indian Medicine Wing Department Of Shalya Tantra, Faculty of Ayurveda,IMS,BHU
Varanasi
UTTAR PRADESH 		 8871502227

ankitsarraf36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IMS BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bandhanakarma, बन्धनकर्म (Procedure Reference: , Procedure details: After cleaning of wound with normal saline, Advanced dressing material impregnated with kshara of butea monosperma & taila of cynodon dactylon will be applied on wound area/ once daily for 28 days or till the complete healing of wound (whichever is earlier))
2Comparator Arm (Non Ayurveda)-BetadineAfter cleaning of wound with normal saline, chemical/surgical wound debridement will be performed as required based on the clinical condition of the wound, gauze soaked with betadine will be applied on wound area / once daily for 28 days or till the complete healing of wound (whuchever is earlier)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Mild and moderately infected wounds of all types
2. Patients with controlled diabetes.
3. Wounds having duration of more than 3 weeks 
 
ExclusionCriteria 
Details  1. Malignant ulcers
2. Tubercular ulcers
3. Syphilitic ulcers
4. Leprotic ulcers and other specific ulcers
5. Wounds with associated osteomyelitis
6. Anaemia (Hb<8g/dl)
7. Jaundice
8. Malnutrition
9. Wounds in HIV positive and immunocompromised patients
10. Severe infection
11. Uncontrolled diabetes 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Assessment of the wound healing activity of Advanced dressing material impregnated with Kshara of Butea Monosperma and Taila of Cynodon Dactylon
2. Assessment of wound healing rate 		 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of wound healing activity of trial drug and control drug  28 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   30/04/2026 
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="8"
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   This randomized controlled clinical trial on dushtavrana (chronic wound) is with objectives of to assess the wound healing activity of Advanced dressing material impregnated with kshara of butea monosperma and taila of cynodon dactylon , to assess the wound healing rate in 28 days and to compare wound healing activity of trial drug and control drug. 
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