| CTRI Number |
CTRI/2025/03/082422 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [lepa application ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study Vranashodhan Kesari Lepa In The Management Of Dushta
Vrana With Special Reference To Infected Wound |
|
Scientific Title of Study
|
A Randomized Clinical Study Of Vranashodhan Kesari Lepa In The Management Of Dushta
Vrana With Special Reference 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 Rahul Popat Thakare |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No.22,Shalya Tantra Department, Vidarbha Ayurved Mahavidyalaya and Hospital, Dhanvantari Nagar, Amravati.
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9960001698 |
| Fax |
|
| Email |
iamrahul22royal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha S Kalmegh |
| Designation |
Guide and HOD Department of Shalyatantra |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No.22,Shalya Tantra Department, Vidarbha Ayurved Mahavidyalaya and GNT Hospital, Dhanvantari Nagar, Amravati.
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9422155851 |
| Fax |
|
| Email |
manjushakalmegh75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Popat Thakare |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No.22,Shalya Tantra Department, Vidarbha Ayurved Mahavidyalaya and GNT Hospital, Dhanvantari Nagar, Amravati.
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9960001698 |
| Fax |
|
| Email |
iamrahul22royal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurved Mahavidyalaya and Hospital, Dhanvantari Nagar,Amravati,444605,India. |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati 444605,India. |
| Type of Sponsor |
Other [self] |
|
|
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 Rahul Popat Thakare |
Vidarbha Ayurved Mahavidyalaya,Amravati |
OPD No.22,Shalya Tantra Department, Vidarbha Ayurved Mahavidyalaya and Hospital, Dhanvantari Nagar, Amravati.
Amravati
Amravati
MAHARASHTRA |
09960001698
iamrahul22royal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M.Vidarbha Ayurved Mahavidyalaya,Amravati |
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 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Dravyagun vidynan uttarardha yadavji, Procedure details: (Procedure Reference: Dravyagun vidynan uttarardha yadavji, Procedure details: Lepa Application details: Before lepa application wound will be cleaned. On first day at morning, Vranashodhan Kesari Lepa will be applied over wound surface and wound be closed by dressing. Route of Administration: Topical Duration:45days Dose: as per wound size (at morning) Dressing : once a day)
(1) Medicine Name: Vranashodhan Kesri Lepa , Reference: Chakradatta 44/28 , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 45 Days
Delete)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 patients who will give consent for the study
2 patients with all types of Dushtavrana with maximum history of more than or equal to 2 weeks and less than 1 month
3 patients having clinical features of nija and agantuja vrana ie foul smell pus discharge pain burning sensation and edema (eg neglected wound post op infected wound body extrimities cellulities wound) will be selected for study |
|
| ExclusionCriteria |
| Details |
1.The patient who has underlying bony lesions
2. Patients with Malignant Ulcer.
3. Tuberculous Ulcer.
4. Lepromatous Ulcer.
5. HIV, HbSAg positive patients.
6. Bleeding disorders.
7. Gangrenous wound.
8.Diabetic Wound will not be selected.
9.Animal bite injuries.
10) Delicate organ injury |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission from dushtavrana (infected wound) .
Marked improvement in dushtavrana (infected wound)
Mild improvement in dushtavrana (infected wound). |
0th day
4th day
7th day
10th day
14th day
17th day
21th day
24th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from all kind of wound
Normal granulation tissue achieved |
31th day
35th day
38th day
42th day
45th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
28/03/2025 |
| 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="10"
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
|
A Randomised clinical trial will be conducted to study the Vranashodhan Kesri Lepa in the management of Dushta vrana with special reference to Wound.
Trial will be conducted in our Institute and its periphery. Total 70 patients diagnosed with infected wound will be selected in the group.
One group will be advised to use Vranashodhan Kesri Lepa on the wound surface.
The study will be done for 60 days. Results will be derived. Data analysis will be done by using appropriate statistical test. Primary outcomes will be to study the Vranashodhan Kesri Lepa and complete, moderate and mild remission of infected wound in patients. |