| CTRI Number |
CTRI/2024/11/077037 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the Effect Of Nimba Pratisarniya kshar in the Management of Dushta Vrana with special reference to Infected wound |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Nimba Pratisarniya Kshar Application 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 Monika Shivaji Dhawane |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa
Dist Sangli
MAHARASHTRA
415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9326700575 |
| Fax |
|
| Email |
monikadhavane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramachandra Shedge |
| Designation |
HOD Professor in Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa
Dist Sangli
MAHARASHTRA
415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Shivaji Dhawane |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa
Dist Sangli
MAHARASHTRA
415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9326700575 |
| Fax |
|
| Email |
monikadhavane@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital PG institute and research center urun islampur Dist Sangli
415409
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Monika Shivaji Dhawane |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa
Dist Sangli
MAHARASHTRA
415409
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 Monika shivaji Dhawane |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa 415409
Sangli
MAHARASHTRA |
9326700575
monikadhavane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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, (2) 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 | - | kShAra-karma, कà¥à¤·à¤¾à¤°-करà¥à¤® | (Procedure Reference: Sushruta Samhita Chikitsa sthana 2/88, Procedure details: Purvakarma
1)All the Patient will be Explained about the procedure and informed written consent will be obtained.
2)Vrana Prakshalana will be done with Normal Saline.
Pradhan karma
1)The Nimba Pratisarniya Kshara will be applied over the wound surface by Darvi Yantra upto 100 matra kala or till Samyak Dagdha lakshanas will be seen.
2)Then wound will be washed with Nimbu Swarasa.
Pashchat Karma-
1)After completion of procedure dressing will be done.
2)Dressing will be done daily.)
(1) Medicine Name: Nimba Pratisarniya Kshara, Reference: Bhavaprakash page no 314, Route: Topical, Dosage Form: Kshara, Dose: 5(mg), Frequency: od, Duration: 28 Days | | 2 | Comparator Arm | Procedure | - | kShAra-karma, कà¥à¤·à¤¾à¤°-करà¥à¤® | (Procedure Reference: Sushruta Samhita Chikitsa sthana 2/88, Procedure details: Purvakarma
1)All the Patient will be Explained about the procedure and informed written consent will be obtained.
2)Vrana Prakshalana will be done with Normal Saline.
Pradhan karma
1)The Nimba Pratisarniya Kshara will be applied over the wound surface by Darvi Yantra upto 100 matra kala or till Samyak Dagdha lakshanas will be seen.
2)Then wound will be washed with Nimbu Swarasa.
Pashchat Karma-
1)After completion of procedure dressing will be done.
2)Dressing will be done daily.)
(1) Medicine Name: Palash Pratisarniya kshar, Reference: Bhavaprakash page no 524, Route: Topical, Dosage Form: Kshara, Dose: 5(mg), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient having sign and symptoms of Dushta Vrana having Area Length 6cm x Breadth 6cm x Depth 6 mm less will be Randomly selected.
2) Patient of Irrespective of Gender, Caste, Religion, Sex, Occupation are taken.
3)Patient aged between 18-60 years.
4)Vrana which are not secondary to Systemic diseases |
|
| ExclusionCriteria |
| Details |
1)Wound with known case of systemic disorders like HIV,Hepatitis B,Known cases of Diabetes Mellitus or any other systemic infection.
2)Vrana (wound) very near to vital organs.
3)Ulcer secondary to any malignancy and Burn wound,Osteomyelitis,Patients suffering from wounds like Tubercular Ulcers, Venous Ulcers Leprotic Ulcers, Malignant Ulcers, Ulcers with Gangrenous changes . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Nimba Pratisarniya Kshar application in the management of Dushta Vrana with special referance to Infected wound. |
Application of kshar on 0th,3rd,6th,9th,12th,15th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study in detail the literature about Dushta Vrana according to Ayurvedic aspect
2. To study in detail the literature about Dushta Vrana according to Modern aspect.
3.To study the concept of Nimba Pratisarniya Kshara.
4.To study the concept of Palash Pratisarniya Kshara. |
Application of kshar on 0th,3rd,6th,9th,12th,15th
days
Follow up-21st,28th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="0"
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 is Randomised controlled clinical study to evaluate the efficacy of Nimba Pratisarniya kshar Application in the management of Dushta vrana with special reference to infected wound. Nimba Pratisarniya kshar and Palash pratisarniya kshar is Vrana Pachan, Vrana Shodhan,Shothagna , Pootihara tridoshashamak properties. The age group taken for study trial will be between 18yr to 60yrs. Ayurvedic formulation will be given on 0th,3rd,6th,9th,12th and 15 days.Follow up on 21st and 28th day. Evaluation of effect of both groups using statistical tools will be done and conclusion will be made. |