| CTRI Number |
CTRI/2025/09/094262 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see and compare the Efficacy of Arka Ksharaplota And Apamarga Ksharaplota in The Management of Dushta Vrana (Putrified Wound) |
|
Scientific Title of Study
|
An Open label Randomized Controlled Clinical Study to Evaluate the Efficacy of Arka Ksharaplota And Apamarga Ksharaplota in The Management of Dushta Vrana (Putrified 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 Aftab Ali |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 14, Ground Floor, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7876136113 |
| Fax |
|
| Email |
aftabali27091998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika |
| Designation |
Associate Proffesor |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 103, First Floor, Department of Shalya Tantra, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9896873083 |
| Fax |
|
| Email |
dranamikashalyavida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika |
| Designation |
Associate Proffesor |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 103, First Floor, Department of Shalya Tantra, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra
HARYANA
136118
India |
| Phone |
9896873083 |
| Fax |
|
| Email |
dranamikashalyavida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies & Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Umri Road, Sector 8 Kurukshetra 136118 Haryana, 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 Aftab Ali |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
Room no 14, Ground Floor, Institute for Ayurved Studies and Research Shri
Krishna AYUSH University Umri Road, Sector 8 Kurukshetra
Kurukshetra
HARYANA |
07876136113
aftabali27091998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of University |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarga kshara, Reference: shushrut samhita, Route: Topical, Dosage Form: Kshara , Dose: 20(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: The gauze piece of size 23cm in diameter will be fixed to double layered circular wooden ring. On first coating Snuhi Ksheera( 50ml) will be smeared on gauze piece and kept in the UV Ksharasutra cabinet and dried. On second coating Snuhi Ksheera( 50ml) will be smeared over the gauze piece followed by Apamarga Kshara ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. On third coating Snuhi Ksheera will be smeared followed by Haridra choorna ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. Stored in sterile polythene bag. ) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arka kshara, Reference: shushrut samhita, Route: Topical, Dosage Form: Kshara , Dose: 20(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: The gauze piece of size 23cm in diameter will be fixed to double layered circular wooden ring. On first coating Snuhi Ksheera( 50ml) will be smeared on gauze piece and kept in the UV Ksharasutra cabinet and dried. On second coating Snuhi Ksheera( 50ml) will be smeared over the gauze piece followed by Arka Kshara ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. On third coating Snuhi Ksheera will be smeared followed by Haridra choorna ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. Stored in sterile polythene bag. ) |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Dushta Vrana (putrified wound) will be selected regardless of sex, religion, or profession. Eligible wounds will have a size of up to 6 cm in diameter or length. The wound types include traumatic, diabetic (control), venous ulcers, or post-surgical wounds (non-infected, granulating). Participants should not have any active systemic infection, with a Total Leukocyte Count (TLC) range between 11,000 - 13,000 µL. Additionally, participants must have normal Bleeding Time (BT) and Clotting Time (CT) values. Only those willing to participate and able to provide written informed consent will be included. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include individuals under 30 or over 70, those with chronic conditions (e.g., tuberculosis, chronic osteomyelitis, malignant ulcers), abnormal BT/CT, HIV, uncontrolled diabetes, snake/insect bite wounds, systemic medications that may affect study outcomes, and pregnant or breastfeeding women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in Healing rate of Dushta Vrana (Putrified Wound) |
1st- 0 Days
2nd- 14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in scoring pattern of sign and symptoms of Dushta Vrana (Putrified Wound) and Improvement in quality of life of patients |
1st- 0 Day
2nd- After completion of Trial
3rd- 1 week after completion of trial
4th- 2 week after completion of trial |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/10/2025 |
| 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 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
|
In this Randomized Comparative Clinical study, 64 patients with Dustha Vrana (Putrified Wound) will be enrolled after meeting the necessary criteria and informed consent. In Group A, 32 patients would be treated with Arka Kshara Plota, prepared by Layering Arka Kshara, Snuhi Kshir and Haridra Churna, applied on Alternate Days according to affected area, And in Group B would also have 32 patients, who would receive Apamarga Kshara Plota prepared by the same method as Arka Kshara Plota, with the same dose of medication and intervals. Before starting the treatment, all patients would be tested for essential investigation to ensure they meet the study’s requirements and informed consent will be taken. The effectiveness of the treatment will be assessed based on wound size reduction and significant improvement in the healing rate, After the treatments, the results will be analyzed statistically |