| CTRI Number |
CTRI/2025/08/093130 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of dushtavrana with apamarga kshartaila in comparison with eusol |
|
Scientific Title of Study
|
Comparative study of apamarga kshartaila versus eusol as desloughing agent w.s.r. to shodhankarma in the management of dushtavrana. A randomised controlled trial |
| 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 Vaishnavi Baburao Charhate |
| Designation |
PG Scholer |
| Affiliation |
Shri Ayurved Mahavidyala,Nagpur |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay
Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman
Nagar,Dhanwantari Marga,Nagpur Maharashtra 440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
09623843775 |
| Fax |
|
| Email |
vaishnavic888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Khobragade |
| Designation |
Associate Professor |
| Affiliation |
Shri Ayurved Mahavidyala,Nagpur |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay
Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman
Nagar,Dhanwantari Marga,Nagpur Maharashtra 440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9987014379 |
| Fax |
|
| Email |
drsandesh1128@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Baburao Charhate |
| Designation |
PG Scholer |
| Affiliation |
Shri Ayurved Mahavidyala,Nagpur |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay
Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman
Nagar,Dhanwantari Marga,Nagpur Maharashtra 440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9623843775 |
| Fax |
|
| Email |
vaishnavic888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyala,Pakwasa Samanvay
Rugnalaya,Hanuman nagar,Dhanwantari marga, Nagpur 440024 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay
Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman
Nagar,Dhanwantari Marga,Nagpur Maharashtra 440024
Nagpur
MAHARASHTRA
440024
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 Vaishnavi Baburao Charhate |
Shri Ayurved Mahavidyalaya |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay
Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman
Nagar,Dhanwantari Marga,Nagpur Maharashtra 440024
Nagpur
MAHARASHTRA
440024
India
Nagpur
MAHARASHTRA |
9623843775
vaishnavic888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, (3) 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 | Drug | Classical | | (1) Medicine Name: Apamarga kshar taila, Reference: Bhaishajyartnavali by Siddhinandan Mishra karnarogadhikar 62/26 page no 969 , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | EUSOL | Medicine Name: EUSOL Route: Topical, Dosage Form: Solution, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients from the age group 18-70 years irrespective of gender,
religion, occupation, and socio-economic status.
2) Patients diagnosed with Dushtavrana.
3)Wound
length upto 10 cm and width upto 10cm
4)Wound without any major complications
5)Wound present more than 4 weeks |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from Malignant ulcers, Syphilitic ulcers ,
Lepromatous ulcer ,diabetic wound and Tubercular ulcers will be
excluded from the study.
2) Patients having history of bleeding disorders and anaemia having
haemoglobin % less than 6 gm
3)Immuno -compromised patients like syphilis, HIV, HBsAg positive
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study may provide use of Apamarga Kshar Taila
as conservative treatment option for
Dushtavrana.
|
At the end of 21 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative effect of desloughing between apamarga kshartaila and eusol in dushtavrana will be assessed |
At the end of 21 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="1"
Months="6"
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
|
This study will be carried out at opd of Shalyatantra department of Pakwasa Samnvay Rugnalaya ,Nagpur .This is an open label randomized controlled trial aims at studying the comparison between desloughing effect of Apamarga Kshar Taila and eusol in dushtavrana patients.Total 36 patients will be included and will be randomly divided into two groups i.e. Group A and Group B each containing 18 patients.Group A will be trial group where patients will receive application of Apamarga Kshar Taila and Group B will be control group will receive application of eusol.Then patients will be observed on 7th,14th and 21st day.All the findings will be recorded in case record form.At the end of trial, collected data will be analyzed and result will be drawn accordingly. |