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CTRI Number  CTRI/2024/03/064102 [Registered on: 13/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Ayurveda Surgical/Anasthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Aragwadh Malahar (ointment) application in comparison with Eusol Dressing in the management of Dushta Vrana (Infected Wound). 
Scientific Title of Study   A randomized controlled clinical trial to evaluate the role of Aragwadh Malahar in comparison with Eusol Dressing 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  Dr. Sonal Sanjay Kshirsagar 
Designation  PG Scholar Shalyatantra 
Affiliation  Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 
Address  Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 Pune Maharashtra 411018 India
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India 
Phone  9689046585  
Fax    
Email  sonalkshirsagar11919@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Babar 
Designation  Professor and H O D of Shalyatantra Department 
Affiliation  Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 
Address  OPD No 3 Shalyatantra Department DR D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 Pune Maharashtra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Babar 
Designation  Professor And H O D of Shalyatantra Department 
Affiliation  Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 
Address  OPD No 3 Shalyatantra Department Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 Pune Maharashtra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 
 
Primary Sponsor  
Name  Dr Sonal Sanjay Kshirsagar 
Address  Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 
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 
Dr Sonal Sanjay Kshirsagar  Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18  OPD No 3 Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra
Pune
MAHARASHTRA 		 9689046585

sonalkshirsagar11919@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr DYPCA and RC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L80-L99||Other disorders of the skin and subcutaneous tissue. Ayurveda Condition: VRANAH, (2) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Eusol DressingWound will be washed with Normal Saline followed by local application of Eusol Dressing. Dressing will be done once in a day for 15 days. Route of administration: Local
2Intervention ArmProcedure-vraNasyaShaShTi-upakramAH, व्रणस्यषष्टि-उपक्रमाः (Procedure Reference: Rasatarangini, Sushrut Samhita, Procedure details: Malahar (ointment) will be processed with mixture of base of Sikhta tail & Aragwadh Patra kwath. )
(1) Medicine Name: Aragwadh Malahar , Reference: Bhavprakash nighantu, Rasatarangini, Sushrut Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: od, Duration: 2 Weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients having sign and symptoms of Dushta Vrana (Infected wound) liek Srava (slough), Durgandha (FOul Odour), Daha (Burning Sensation), Vedana (Pain), Kandu (Itching). Those who are willing and fulfill out of from these criteria will be included. Dushta Vrana size mazimum upto 5cm x 5cm x 1cm (length x breadth x depth), patients of controlled Hypertension and Diabetes Mellitus on their regular medicines will be included. 
 
ExclusionCriteria 
Details  Patients having diseases like severe septicemia, severe anemia (Hb less than 8), Uncontrolled Diabetes Mellitus. The patients suffering from systemic disease such as Malignancy, Varicose Ulcer, Deep vein Thrombosis, Arterial Ulcer, Neurogenic Ulcer, Leprosy, Pregnancy, Leukemia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate shodhan (cleansing) effect of Aragwadh Malahar on Vranastrava and Vranakandu in Dushta Vrana (Infected wound).  Dressing will be done once in a day for 15 days. Assessment will be done on 3rd, 7th and 15th day. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effect of Aragwadh Malahar (ointment)  On completion of treatment 
 
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)   15/04/2024 
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 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   A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE ROLE OF ARAGWADH MALAHAR IN COMPARISON WITH EUSOL DRESSING IN MANAEMENT OF DUSHTA VRANA(INFECTED WOUND). TO OBSERVE THE EFFECT OF ARAWADH MALAHAR IN COMPARISON WITH EUSOL DRESSING IN  THE MANAGEMENT OF INFECTED WOUND . TOTAL 60 PATIENTS WILL BE ENROLLED WITH THE SIGN AND SYMPTOMS OF DUSHTA VRANA (INFECTED WOUND).30 PATIENTS IN EACH GROUP DIAGNOSED WITH DUSHTA VRANA WILL BE TREATED WITH ARAGWADH MALAHAR(OINTMENT) AND OTHER 30 PATIENTS WITH EUSOL DRESSING FOR TOPICAL APPLICATION.ASSESMENT WILL BE DONE ON 7TH AND 15TH DAY AND CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHOD. 
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