| CTRI Number |
CTRI/2025/12/098418 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
local dressing of Doorvadi taila vikeshika in dushta vrana. |
|
Scientific Title of Study
|
Randomized open labelled controlled clinical
trial to evaluate the efficacy of Doorvadi Taila
Vikeshika dressing in the management of Dushta Vrana
with special reference to Traumatic 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 |
Ankita Ashokrao Sulkekar |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Shalyatantra department, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9607643875 |
| Fax |
|
| Email |
drankitasulkekar9766@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajendra H Amilkanthawar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Shalyatantra department, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajendra H Amilkanthawar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
shalyatantra department, Government Ayurved College, Nanded
MAHARASHTRA
431601
India |
| Phone |
9890569621 |
| Fax |
|
| Email |
drarajendrah@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College, Nanded- 431601 Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Government Ayurved college Nanded |
| Address |
Shalyatantra department, Government Ayurved College, Nanded- 431601, maharsahtra, 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 Ankita Ashokrao Sulkekar |
Government Ayurved College, Nanded |
Shalyatantra department,Government Ayurved College, Vajirabad, Nanded-431601, Maharshtra, India
Nanded
MAHARASHTRA |
9607643875
drankitasulkekar9766@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Ayurved College, Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | 1% Framycetin sulphate | it is local application on dushta vrana for 28days daily application dressing | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Doorvadi Taila Vikeshika, Reference: charak chikitsa sthan 25/93-94, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Vikeshika dressing in dushta vrana |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Infected Abrasion/Laceration/Incised Traumatic infected wound.
150 Patients with dushta vrana (Traumatic infected wound) of more than seven days duration.
Patients irrespective of gender, religion, occupation and socio-economic status will be selected.
Age – 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic illnesses like DM, HTN, TB, HIV, HBsAg positive, Leprosy, Syphilis, venous ulcer, Arterial ulcer, Malignancy.
Patients suffering from gangrene, burns, sepsis.
Patients with bleeding disorders.
Patients having other organic/infectious illness.
Any other acute illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reducing size of wound or complete healing of wound in 28days |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| healing of wound and associate symptoms. |
follow up on 0,7,14,21,28 days and final assessment on 28 day |
To study the shodhan and ropan effect of Doorvadi Taila Vikeshika
dressing in management of dushta vrana.
To compare the result of Doorvadi Tila Vikeshika and 1% Framycetin
sulphate dressing in the management of dushta vrana.
To propose an alternative cost effective easily available herbal
Preparation in management of dushta Vrana.
To collect literature of dushta vrana according to Ayurvedic and Modern
text. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/12/2025 |
| 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="3"
Months="0"
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
|
The Prevalence of wounds is 15.03 per 1000. The
Prevalences of Acute and Chronic wounds were 10.55 and 4.48 per 1000 of the
Population respectively.
To avoid the higher systemic and local complications
caused by infected wound.
To avoid surgical interventions like debridement of
wound which is invasive and painful treatment.
Doorva, Daruharidra, tila taila production is on very
large amount in India so we can make cost effective wound care product from it.
Vikeshika dressing has easy application for wound
management.
We need more Ayurvedic local drug applications on
wound which should be Cost effective, Non- invasive, Not causing any side
effect, easily available to all Socio-economic classes.
To cope up with other Pathies it is need of the hour
for Ayurveda to make evidence-based medicine in such diseases for universal
acquiescence. And to prove valuable hidden treasures of Ayurveda literature
Samhitas as source of evidence-based research in Samhita kaal. |