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CTRI Number  CTRI/2023/11/060378 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 22/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Wound Cleansing]  
Study Design  Single Arm Study 
Public Title of Study   Herbo-Mineral Solution having potential antimicrobial properties in cleansing of infected wounds.  
Scientific Title of Study   An Experimental And Clinical Pilot Study To Evaluate The Efficacy Of Herbo-Mineral Solution In The Management Of Dushta Vrana With Special Reference To Debridement Of 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 Megha Jadhav 
Designation  Post Graduate Scholar 
Affiliation  Parul Institute Of Ayurveda 
Address  OPd No 106 Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Vadodara
GUJARAT
391760
India 
Phone  9767012312  
Fax    
Email  13meghavj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemant Toshikhane 
Designation  Dean and Principal, Parul Institute of Ayurveda 
Affiliation  Parul Institute Of Ayurveda 
Address  OPd No 106 Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Vadodara
GUJARAT
391760
India 
Phone  8469496525  
Fax    
Email  hemant.toshikhane@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Megha Jadhav 
Designation  Post Graduate Scholar 
Affiliation  Parul Institute Of Ayurveda 
Address  OPd No 106 Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Vadodara
GUJARAT
391760
India 
Phone  9767012312  
Fax    
Email  13meghavj@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute Of Ayurveda Parul University Limda Vadodara Gujarat 
 
Primary Sponsor  
Name  DepartmParul Institute Of Ayurveda Parul University Waghodia Road Vadodara Gujarat India 
Address  Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat 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 Megha Jadhav  Parul Ayurveda Hospital   OPD No 106 Department Of Shalya tantra Parul Ayurveda Hospital Parul University Waghodia Road Vadodara Gujarat India
Vadodara
GUJARAT 
9767012312

13meghavj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee for human research, Parul institute of Ayurveda,Parul unive rsity(PU/PIA/IEC/04/2022/135)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Herbo-mineral Solution , Reference: Sushruta Samhita Sutrasthana Chikitsasthana, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 5(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Herbo-Mineral Solution prepared with Hot Percolation Method
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of Dushta Vrana will be selected irrespective of gender, religion, occupation and socio-economic status
2.Patients between 20-60 years of age
3.Patients suffering from Dushta Vrana as per classic 
 
ExclusionCriteria 
Details  1. Malignancy 2. Syphilis 3. Tuberculosis 4. Leprosy 5. HIV+ve 6. HBsAg+ve
7. VDRL+ve 8. Burns 9. Uncontrolled Diabetes mellitus 10. Ostiomylitis
11. Anaemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early Wound Cleansing and Healing  Early Wound Cleansing and Healing within 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
early wound cleansing with assessment on 7th 14th 21st and on 28th day  7th 14th 21st and on 28th day 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   01/12/2023 
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="0"
Months="1"
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  
As per Ayurveda wound is explained in the chapter of Vrana. Which is defined as “Vrana gatra vichurnane vranayati iti vranaha” meaning the destruction / break / rupture / discontinuity of the body tissues is called as  Vrana. So, “Vrana Gatra Vichurnane”i means phenomenon complex causing destruction or Rupture or discontinuation of tissues in a particular part of the body which is termed as Vrana, whereas Vranayati means discoloration.
Hence, the definition of Vrana implies the damage of a part of the body leading to disfigurement and discoloration. In Sushruta Samhita, Acharya has clarified that as the Vranavastu (scars) of a Vrana (wound) never disappears after complete healing and its imprint persists lifelong, that lesion is called as Vrana. 
Aacharya Sushruta has described 2 types of vrana e.g. sharira and aagantuja. Dustha vrana and its detail signs e.g. atisanvruta, ativivruta, ati kathina, atimrudu etc are described in
chapter of  Vranasrava vignaniya.. Aacharya Sushruta  also mentioned other details of vrana e.g. vranasrava, vranavarna, vranasthana etc. and its management which is of prime importance in any surgical practice or procedure.
As dusta vrana (inected wounds) are a frequently encountered problem in present era commonly as a complication of trauma and pathological insult. Dustha vrana are long lasting and non-healing ulcer, where removing debris to reach healthy tissues is a prime focus. So we can say that  in dusta vrana there is localization of dosha that prevents vrana to heal and disturbs natural process of healing. By seeing its aspect of management we should treat this type of vrana  as early as possible so that we can prevent delayed  healing causing factors.
Acharya sushruta  was aware of importance of vrana management, so he mentioned 60 upakramas  for vrana  management which include local as well as the systematic use of different drugs and treatment modalities under dedicated chapters.
Acharya Sushruta “The Father of Indian Surgery” has explained  Vrana in detail in his classical text “Sushruta Samhita”.The term Wound is a discontinuity or break in the surface epithelium. A wound is simple when only skin is involved. It is complex when it involves underlying nerves, vessels and tendons.

Worldwide prevalence of wound ranges from 0.18% to 0.32% of world population and incidence is 0.78% of population. Prevalence of wounds in Indian population is 4.48/1000.There are many different types of wounds even though all the wounds follow the same healing process roughly.
As the science have advanced, newer therapies are tried out to boast up cleansing and the recovery process, but the oldest remedies still lead the race. Aacharya sushruta has explained Vrana in detail in his classical text and many Vrana Shodhana dravyas for the same and that still holds its place today.
 
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