| CTRI Number |
CTRI/2025/02/081033 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See Effect Of Ayurvedic Panchvalkal Malhar in Treatment of Dustha Vran with Reference to Infected wound |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial to Study the Efficacy Of Panchvalkal Malhar In Management Of Dusta vran WSR 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 |
DrDipali vilas raut |
| Designation |
MS shalyatantra scholar (Ayurveda) |
| Affiliation |
VJD GRAMIN ayurvedic clg patur akola |
| Address |
Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata
mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA
INDIA
Akola
MAHARASHTRA
444501
India
Akola
MAHARASHTRA
444501
India |
| Phone |
08698912112 |
| Fax |
|
| Email |
dipalivraut6111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Mavle |
| Designation |
Professor and Head of the Department,Shalyatantra |
| Affiliation |
VJD GRAMIN ayurvedic clg patur akola |
| Address |
OPD NO 18 Department of shalyatantra,Dr.VJD Gramin Ayurved
Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Pin-444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India
Akola
MAHARASHTRA
444501
India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Mavle |
| Designation |
Professor and Head of the Department,Shalyatantra |
| Affiliation |
VJD GRAMIN ayurvedic clg patur akola |
| Address |
OPD NO 18 Department of shalyatantra,Dr.VJD Gramin Ayurved
Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Pin-444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India
OPD NO 18 Department of shalyatantra,Dr.VJD Gramin Ayurved
Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Pin-444501 MAHARASHTRA INDIA
Akola
MAHARASHTRA
444501
India
MAHARASHTRA
444501
India |
| Phone |
9850500860 |
| Fax |
|
| Email |
gayatriakola@gamil.com |
|
|
Source of Monetary or Material Support
|
| Department of shalyatantra,DrVJD Gramin ayurvedic mahavidhyala,patur,dist akola,Maharashtra,India pincode 444501 |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin ayurvedic mahavidhyala |
| Address |
DrVJD Gramin ayurvedic mahavidhyala near renuka mata mandir balapur road patur, tal patur, dist akola Maharashtra, India , pincode 444501 |
| 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 Dipali raut |
Dr.VJD Gramin Ayurved Mahavidyalaya |
OPD no.18 , Department
of shalyatantra,Dr.VJD
Gramin Ayurved
Mahavidyalaya,near
Renuka mata mandir,P
atur,Tal-Patur,Dist-Akol
a
Akola
MAHARASHTRA
Akola
MAHARASHTRA |
08698912112
dipalivraut6111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr.VJD Gramin mahavidhyala Patur Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchvalkal malahar, Reference: Sushruta samhita , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: -, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , 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. (dushta vrana)
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. |
|
|
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.Vedana
2.strava
3.Raktavrna
4.daurbalya |
5 days,10 days, 15 days after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased symptoms of Dusta vran |
28 days |
|
|
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)
|
03/03/2025 |
| 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="0"
Months="1"
Days="6" |
|
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
|
Vran and its Managment has been dot since period of veda Current era. It has been a major problem Since early stage of Medical Science Non-healing wound present serious problem for paitent family, and clinician Most of wound associated with a small Number of underderlying disorders such as DM., Lepray and peripheral disease. Wound areCommon place from childhood to old age and some time it Requird surgical intervention.Drusta means getting vitiated by Doshos which one such long standing ulcer with profuse discharge and slough. The or wound healing denotes to surgray is major challenge so surgeons which has been extensively in Ayurveda. In fact vrana healing are two Side of Surgical coin on which surgeon plays important role. Wound management physician assist nature, by cleansing and Removal of dead tissue from wound & applied of application of local dressing on wound to creat a Moist environment. medicine is also known art of healing .while curative Method are being refined and devlop at a Rapid pace And healing remain prime objective of physician. Various factor are Responsible for improper healing of vrana which are vascular insuffi ciency, contamination of wound disease like D.m, T.B.; Anemia and Maligency. Sushruta an emient surgeon of his era was much ahead of his time in expanding and practing and beautiful concept of vrana ropana .The aim of wound healing according to Aacharya sushruta are many of herbs of heabomineral 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 maintance of moisture presence of or Replicating micro- organism result in pus, foul odour and discharge leads to deadly wound healing. Sushruta has formulate 60 procedure i.e shasthi Upkram for management of vrana managmentof vrana along with numerous drug. charak has mention the 36 procedure of Vrana upkram. |