| CTRI Number |
CTRI/2021/01/030398 [Registered on: 12/01/2021] Trial Registered Prospectively |
| Last Modified On: |
11/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to see the effect of Vrana Lepa in non-healing ulcers |
|
Scientific Title of Study
|
Clinical study to evaluate the effectiveness of Vrana Lepa in Dushta Vrana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritheka B Rao |
| Designation |
PG Scholar Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept of Shalya Tantra OPD 12 Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
09513399895 |
| Fax |
|
| Email |
pg19162@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna N Rao |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept of Shalya Tantra OPD 12 Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna N Rao |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept of Shalya Tantra OPD 12 Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hassan BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan
573201 Karnataka india |
| Type of Sponsor |
Private medical college |
|
|
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 Ritheka B Rao |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Dept of Shalya Tantra
OPD 12
Hassan
KARNATAKA |
09513399895
pg19162@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vrana Lepa |
Quantity as required depending on wound size
Route of administration is topical application with Murchita Ghrita as a lepa
Till the wound heals or for a duration of 21 days whichever comes earlier |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Ulcer not healed within 3 weeks
Ulcer within size of 7x7 cms |
|
| ExclusionCriteria |
| Details |
Tuberculosis
Malignant ulcers
Human Immunodeficiency deficiency virus
Hepatitis B
Buergers disease
Osteomyelitis
Uncontrolled Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vrana Vedana
Daha
Kandu
Vrana Gandha
Vrana varna
Vrana srava
Vrana akruti |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale
assessment of pain
Assessment of size
Assessment of tenderness
Assessment of burning sensation
Assessment of itching
Assessment of colour
Assessment of Margin and surface
Assessment of base/floor
Assessment of smell
Assessment of swelling
Assessment of discharge
Assessment of unhealthy granulation tissue |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/01/2021 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective study, an open label single arm exploratory clinical trial to evaluate the effectiveness of Vrana Lepa in Dushta Vrana in 30 patients. |