| CTRI Number |
CTRI/2025/11/097300 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A trial to compare eefect of Aragvadha Kshara and Apamarga Kshara in chronic Wounds" |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Aragvadha Kshara and Apamarga Kshara application in Dushta Vrana |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayak Leena |
| Designation |
Associate Professor |
| Affiliation |
N.K.JABSHETTY AYURVEDIC MEDICAL COLLEGE AND PG CENTRE BIDAR |
| Address |
DEPARTMENT OF SHALYA TANTRA,
N.K.JABSHETTY AYURVEDIC MEDICAL COLLEGE AND PG CENTRE BIDAR
Bidar
KARNATAKA
585403
India |
| Phone |
7892269773 |
| Fax |
|
| Email |
leenanayak43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. CHANDRAKANTH MAHADEVAPPA HALLI |
| Designation |
PROFESSOR AND H.O.D |
| Affiliation |
N.K.JABSHETTY AYURVEDIC MEDICAL COLLEGE AND PG CENTRE BIDAR |
| Address |
N.K.JABSHETTY AYURVEDIC MEDICAL COLLEGE AND PG CENTRE BIDAR
KARNATAKA, INDIA
Bidar
KARNATAKA
585403
India |
| Phone |
9448222610 |
| Fax |
|
| Email |
drchalli42@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayak Leena |
| Designation |
Associate Professor |
| Affiliation |
N.K.JABSHETTY AYURVEDIC MEDICAL COLLEGE AND PG CENTRE BIDAR |
| Address |
DEPARTMENT OF SHALYA TANTRA,
N.K.JABSHETTY AYURVEDIC MEDICAL COLLEGE AND PG CENTRE, GUMPA, BIDAR
Bidar
KARNATAKA
585403
India |
| Phone |
7892269773 |
| Fax |
|
| Email |
leenanayak43@gmail.com |
|
|
Source of Monetary or Material Support
|
| N.K.J. AYURVEDIC MEDICAL COLLEGE & P.G CENTRE, BIDAR-585 403.
KARNATAKA (INDIA).
|
|
|
Primary Sponsor
|
| Name |
DR NAYAK LEENA |
| Address |
N.K.J.AYURVEDIC MEDICAL COLLEGE, GUMPA, BIDAR, PIN: 585403 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR LEENA |
N.K.J. AYURVEDIC MEDICAL COLLEGE & P.G CENTRE |
DEPARTMENT OF SHALYA TANTRA,
RAMPURE COLONY, GUMPA, BIDAR
Bidar
KARNATAKA |
7892269773
leenanayak43@gmail.com |
| DR NAYAK LEENA |
SSAMC BIDAR |
SRI SIDDHARAMESHWAR AYURVEDIC MEDICAL COLLEGE NAUBAD BIDAR
Bidar
KARNATAKA |
7892269773
leenanayak43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| N K JABSHETTY AYURVEDIC MEDICAL COLEGE AND PG CENTER BIDAR |
Approved |
| SRI SIDDHARAMESHWARA AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z736||Limitation of activities due to disability. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:Z729||Problem related to lifestyle, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ARAGVADHA KSHHARA APPLICATION AND APAMARGA KSHARA APPLICATION, Reference: SUSHRUTA SAMHITA SUTRA STHANA, Route: Topical, Dosage Form: Kshara , Dose: 2(mg), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: IT WILL BE APPLIED OVER DUSTHA VRANA TILL SUDDHA AKSHANAS | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: APAMARGA KSHARA, Reference: APAMARGA KSHARA, Route: Topical, Dosage Form: Kshara , Dose: 10(g), Frequency: od, Bhaishajya Kal: Samudga, Duration: 20 Days, anupAna/sahapAna: No, Additional Information: KSHARA WILL BE LOCALLY APPLIED OVER THE DUSTHA VRANA TILL VRANA SUDDHA LAKSHANAS |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A.Patients with controlled type 2 diabetis melitus
B.Subjects suffering from non-healing ulcer / wound - bad smell (Puti Gandha), abnormal colour (Vikruta Varna) with profuse discharge (Srava), severe pain (Vedana), deformity (Vikruti), Hypergranuation (utsanna mamsa), Itchhing(Kandu), Hard(Kathina) and longer healing time
C.Size of the Dushta vrana will be of 10cm |
|
| ExclusionCriteria |
| Details |
A.Patient with Un Controled Diabetes Mellitus, Tubericulosis Malignancy.
B.Subjects with disorders like Tuberculosis, Leprosy, HIV, Vascular ulcers, Decubitus ulcers, Malignancy and underlying bony lesions.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEALING OF DUSTHA VRANA |
HEALING OF DUSTHA VRANA
CONVERSATION OF DUSTHA VRANA INTO SHUDDHA VRANA WITH IN 4 WEEKS OR 28 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BETTER HEALING OF DUSTHA VRANA AND CONVERSION OF DUSTHA VRANA IN TO SHUDDHA VRANA |
MUCH IMPROVEMENT SEEN WITH IN 6 WEEKS OR 42 DAYS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
Healing of vrana is a natural process, yet it is inhibited by various factors and leads into Dushta Vrana. If the wounds are not treated properly it may lead to secondary infections, delayed healing, gangrene, etc. Sometime skin grafting is also indicated when wound is deep and larger in size. “Chronic wound is a wound that has failed to proceed through an orderly and timely process to produce anatomic and functional integrity”. To achieve good approximation, early healing and acceptable scar without complications Acharya Sushruta has elaborately explained 60 types of procedures (Shastiupakramas). Also mentioned use of Kshara in Shashtiupakrama. In Ksharapakavidhi Adhyaya, Acharya Sushruta mentioned about dravyas which can be used for Kshara and indicated in the treatment of Dushta Vrana. Among these drugs Aragvadha is also one. Aragvadha kshara is such a kshara which is neither included in Kshara dwaya, Kshara traya, Kshara panchaka, Ksharastaka nor frequently used for the management of wounds. As Aragavadha (Cassia fistula Linn) is easily available, cost effective and non-controversial which is frequently used for the management of kustha, jwara, vibanddha etc. and no clinical research has been carried out by using Aragvadha kshara in Dushta Vrana. So keeping this in view A comparative clinical study to evaluate the efficacy of Aragvadha Kshara and Apamarga Kshara application in Dushta Vrana was conducted.
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