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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 Vichurnaneâ€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 Samhitaâ€.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. |