| CTRI Number |
CTRI/2025/03/082359 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the Healing Benefits of Vrana Ropak Tail for Infected Wounds in Adults Aged 20 to 60 Years |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Vrana Ropak Tail in Management of Dushta Vrana W.S.R. to 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 Rameshwar Bhujang Khedkar |
| Designation |
MS Shalyatantra Scholar |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir Patur Dist Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
7030544299 |
| Fax |
|
| Email |
rameshwarkhedkar7030@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGayatri Dipak Mawale |
| Designation |
Professor and Head of The department shalyatantra |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur, tq. Patur Dist. Akola |
| Address |
OPD no Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur, tq. Patur Dist. Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGayatri Dipak Mawale |
| Designation |
Professor and Head of The department shalyatantra |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur, tq. Patur Dist. Akola |
| Address |
OPD no Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur, tq. Patur Dist. Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata Mandir, Patur Dist Akola 444501 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya, Near Renuka Mata Mandir Patur Dist Akola 444501 Maharashtra 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 Rameshwar Bhujang Khedkar |
Dr VJD Gramin Ayurved Mahavidyalaya |
OPD No 18 Department of Shalyatantra
Near Renuka Mata Mandir Patur Dist Akola 444501
Akola
MAHARASHTRA |
7030544299
rameshwarkhedkar7030@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee Dr. V.J. Dhone G.A.M. Patur Dist. Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B968||Other specified bacterial agents as the cause of diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Betadine ointment | Applied locally as per size of wound once in a day for 21 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vranaropak Tail, Reference: Sahastra Yoga Tail Prakrana 67 , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All infected wound
2.Chronic non healing wound
3.Wound size up to 5cm by 5cm
4.Patients will be selected irrespective of their gender, caste and socioeconomic status
5.Patient age 20 to 60 yrs will be included
6.Patients ready to give written consent will be selected
7.Wound depth upto Masadhatu |
|
| ExclusionCriteria |
| Details |
1.Wound created by T.B
2.Burn wounds
3.Leprosy wounds
4.Wound having excessive loss of tissue
5.Patient having malignant ulcers
6.Osteomyelitis
7.Size of wound more than 5cm
8.Patient suffering from HIV, HbsAg, DM
9.Bleeding disorder
10.Patient on aspirin and other antiplatelet drugs
11.Gangrenous
12.Less than 20 yrs and more than 60 yrs of age
13.Wound depth beyond the Masadhatu
14.Medicolegal cases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pariman of Vrana (size of wound)
2.Strava of Vrana (discharge)
3. Strava Ghatak of vrana (discharge content)
4.Gandha of vrana (smell)
5.Vedana of vrana (pain)
6.Varna of vrana (colour)
7.Duration of healing
|
Assesment before and after Treatment and follow up at 3,5,7,10,15,21 and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Dustavrana |
18 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="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
|
Vrana and its management has been dotted since period of Veda to Current era. It has been a major problem Since early stage of medical science non-healing wound present serious problem for patient family, and clinician. Most of wound associated with a small number of under lying disorders such as DM, Leprosy and peripheral disease. Wound are Common place from childhood to old age and some time it required surgical intervention.
Dusta means getting vitiated by doshas which one such long standing ulcer with profuse discharge and slough. Vrana healing are two Side of Surgical coin on which surgeon plays important role.
Wound management assisted by cleansing and removal of dead tissue from wound & application of local dressing on wound to create a moist environment. Various factors responsible for improper healing of vrana are vascular insufficiency, contamination of wound disease like D.M, T.B.; Anemia and Malignancy.
Sushruta an eminent surgeon of his era was much ahead of his time in expanding and practicing and beautiful concept of vrana ropana. The aim of wound healing according to Aacharya Sushrut are many of herbs of Herbo-mineral combination for a Vrana Shodhana and ropana activity, for proper healing of wound it is essential to decrease microbial burden, removing on unhealthy slough, necrotized tissue and maintains moisture presence.
Sushruta has formulated 60 procedures i.e. Shashti Upkrama for management of vrana management of vrana along with numerous drugs. Charka has mentioned the 36 procedures of Vrana upkrama. |