| CTRI Number |
CTRI/2026/02/103810 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Apamarga Ksharajala spray in patients With dushta vrana . |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to evaluate the efficacy of Apamarga Ksharajala Spray in 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 |
DrAshwini |
| Designation |
Post graduate scholar , Department of Shalya Tantra |
| Affiliation |
Shri Dharmastala Manjunatheshwara institute of ayurveda and hospital,Bangalore |
| Address |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital , Anchepalya , Kumbalagodu post, Bengalore
Karnataka
560074
Bengalore
Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9606339469 |
| Fax |
|
| Email |
ashwinigangapure37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parvathy S |
| Designation |
Associate professor |
| Affiliation |
Shri Dharmastala Manjunatheshwara institute of ayurveda and hospital,Bangalore |
| Address |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital , Anchepalya , Kumbalagodu post, Bengalore
Karnataka
560074
Bengalore
Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9746120528 |
| Fax |
|
| Email |
drparvathy20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAshwini |
| Designation |
Post graduate scholar , Department of Shalya Tantra |
| Affiliation |
Shri Dharmastala Manjunatheshwara institute of ayurveda and hospital,Bangalore |
| Address |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital , Anchepalya , Kumbalagodu post, Bengalore
Karnataka
560074
Bengalore
Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9606339469 |
| Fax |
|
| Email |
ashwinigangapure37@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr ASHWINI |
| Address |
SDM Institute of Ayurveda and hospital
Anchepalya, Kumbalagodu Post,
Bengaluru -560074 |
| 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 |
| DrAshwini |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital ,Anchepalya , Kumbalagodu post, Bengalore
Karnataka
560074
Bengalore
Karnataka
Bangalore
KARNATAKA |
09606339469
ashwinigangapure37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,SDM Institute of Ayurveda and Hospital bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L97||Non-pressure chronic ulcer of lower limb, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Apamarga ksharajala spray, Reference: sushruta samhita kshara kalpana adhyaya, Route: Topical, Dosage Form: Kshara , Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -The drug will be applied locally over the cleaned wound once daily for the specified study duration under aseptic precautions. | | 2 | Comparator Arm (Non Ayurveda) | | - | Oxum spray | Oxum Spray will be applied locally over the infected wound once daily under aseptic precautions for the specified study duration. The spray will be used in sufficient quantity to cover the wound surface as per standard usage guidelines. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting with the features of Dushta vrana , age between 18 to 70 years, irrespective og gender,religion,socioeconomic status and place.
wound size length 5cm,breadth 4cm and depth less than 3cm and chronicity of the ulcer more than 7 days and less than 1 year . |
|
| ExclusionCriteria |
| Details |
Patients aged below 18 years and above 70 years.
Patients suffering from malignancy, tuberculosis, systemic diseases, uncontrolled diabetes mellitus, leprosy, deep vein thrombosis, or hepatitis B.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the status of the Dushta Vrana,Reduction of pain
and tenderness. |
Day 1 (Before treatment)
Day 8 (After treatment )
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Quality of Life. |
Day 1 (Before treatment)
Day 8 (After treatment )
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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 is a randomized, parallel group, active-controlled clinical trial designed to evaluate the efficacy of Apamarga Ksharajala Spray in the management of Dushta Vrana. A total of 30 patients fulfilling the diagnostic and inclusion criteria of Dushta Vrana will be randomly allocated into two groups. Group A will receive Apamarga Ksharajala Spray, while Group B will receive Oxum spray as the control intervention. The treatment will be administered locally over the wound for a specified duration as per the study protocol. The assessment of wound healing will be carried out using the Bates–Jensen Wound Assessment Tool, along with evaluation of pain and tenderness. Quality of life will be assessed as a secondary outcome. The study aims to scientifically evaluate the wound cleansing and healing potential of Apamarga Ksharajala Spray and to compare its efficacy with the control intervention. The data obtained will be statistically analyzed to determine the therapeutic effectiveness of the intervention. All patient information will be kept confidential, and the study will be conducted following ethical guidelines. |