| CTRI Number |
CTRI/2025/06/088656 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
tool development |
| Study Design |
Other |
|
Public Title of Study
|
Development of Ayurvedic wound assessment tool for non healing ulcers |
|
Scientific Title of Study
|
Development and Validation of a Comprehensive Wound Assessment Tool Based on Ayurveda Principles for Non healing ulcers with special reference to Dushta Vrana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aadithyaraj K T |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department Of Shalya Tantra
All India Institute of Ayurveda
Sarita Vihar
New Delhi
South
DELHI
110076
India |
| Phone |
9496838939 |
| Fax |
|
| Email |
aadithyaraj.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogesh Badwe |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department Of Shalya Tantra
All India Institute of Ayurveda
Sarita Vihar
New Delhi
South
DELHI
110076
India |
| Phone |
9011060498 |
| Fax |
|
| Email |
dryogesh.badwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Badwe |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Shalya Tantra
All India Institute Of Ayurveda
Sarita Vihar
New Delhi
South
DELHI
110076
India |
| Phone |
9011060498 |
| Fax |
|
| Email |
dryogesh.badwe@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Sarita Vihar, New Delhi, 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Sarita Vihar, New Delhi, 110076 |
| Type of Sponsor |
Research institution |
|
|
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 Aadithyaraj K T |
All India Institute of Ayurveda |
Department of Shalyatantra, 5th Floor, Academic block
South
DELHI |
9496838939
aadithyaraj.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L899||Pressure ulcer of unspecified site. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study
Irrespective of sex, religion, occupation and socio-economic status |
|
| ExclusionCriteria |
| Details |
Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| development and validation of a comprehensive wound assessment tool based on Ayurveda principles, incorporating a standardized scoring system. |
20 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| define classification criteria for non-healing ulcers based on Ayurveda principles & establish corresponding scoring ranges for each parameter. |
20 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/07/2025 |
| 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 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
|
Despite modern advancements, non-healing ulcers continue to be a clinical and financial burden. Current wound assessment tools often neglect holistic and systemic factors crucial for comprehensive treatment. Ayurveda’s concept of Dushta Vrana, emphasizing dosha imbalances and individualized diagnosis, aligns with modern understandings but lacks standardized tools for consistent application. There is a need for a validated wound assessment tool based on Ayurvedic principles to bridge this gap, enhance reproducibility in research, and integrate holistic approaches into modern wound care. This tool would standardize assessments, improve clinical outcomes, and foster collaboration between Ayurvedic and contemporary medical practices. |