| CTRI Number |
CTRI/2024/11/077110 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To test the effectiveness of Sharad patra kashay vrana dhawan for treating infected wound |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study to Evaluate The Efficacy of Sharad Patra Kashay Vrana Dhawan in 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 |
Vijay Marutirao Deshmukh |
| Designation |
PG Scholar Pre Ms shalyatantra |
| Affiliation |
Yashwant Ayurvedic College P.G. Training And Research Centre |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre shalyatantra department OPd NO.3,4 and IPD NO.136 Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8446477254 |
| Fax |
|
| Email |
vj.deshmukh09.v0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Marutirao Deshmukh |
| Designation |
PG Scholar Pre Ms shalyatantra |
| Affiliation |
Yashwant Ayurvedic College P.G. Training And Research Centre |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre shalyatantra department OPd NO.3,4 and IPD NO.136 Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8446477254 |
| Fax |
|
| Email |
vj.deshmukh09.v0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ardra Thorat |
| Designation |
PG Guide Associate Professor Shalyatantra Department |
| Affiliation |
Yashwant Ayurvedic College P.G. Training And Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre shalyatantra department OPd NO.3,4 and IPD NO.136 Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9970223088 |
| Fax |
|
| Email |
drardrathorat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College P.G. Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114 state Maharashtra, Country India
|
|
|
Primary Sponsor
|
| Name |
Dr Vijay Marutirao Deshmukh |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114 State Maharashtra Country 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 Vijay Marutirao Deshmukh |
Yashwant Ayurvedic College P.G. Training And Research Centre |
shalyatantra department OPd NO.3,4 and IPD NO.136 Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
8446477254
vj.deshmukh09.v0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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 | Intervention Arm | Procedure | - | vraNasyaShaShTi-upakramAH, वà¥à¤°à¤£à¤¸à¥à¤¯à¤·à¤·à¥à¤Ÿà¤¿-उपकà¥à¤°à¤®à¤¾à¤ƒ | (Procedure Reference: Sushrut Sutrasthan 36/12, Procedure details: POORVAKARMA 1. Freshly prepared Sharad Patrak Kashaya will be taken adequate quantity. 2) Informed consent of Patient will be taken. 3) Patient affected area will be cleaned properly prior to vrana dhawan. PRADHANKARMA- 1) Proper Aseptic measures should be insure before starting the procedure. 2) Take luke warm sharad Patra kashay as per requirement. 3) Washout the dushta vrana by sharad patra kashay for 10 15 minutes and simultaneously clean the wound by sterile guaze. 4) Sterile Dry Gauze will kept over the dushta vran and dressing will be done.
PASCHYATKARMA- 1) Area around the wound will be cleaned properly. 2) Bandage will be done on the wound site.
3) Internal Medicine Triphala Guggule 500mg 1tab BD Orally
Duration of treatment for 15 days. ))
(1) Medicine Name: Sharad Patra, Reference: Bhavprakash Vatadi varga 74 75, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Hydrogen Peroxide and Povidone Iodine Solution | Hydrogen Peroxide and Povidone Iodine Solution external application as per requirement in amount Daily for 15 days along with Triphala guggul 500mg 1 tab twice a day orally |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Dushta Vrana with diamensions
measuring as follow length upto 4 cm breadth
upto 4cm and depth upto 1cm.
2) Age from 16 years to 70 years.
3) Patients irrespective of gender economic class
caste religion
4) Patients not suffering from any severe systemic
Disease
5) Patients of control Diabetes Mellitus BSLR 200
mg/dl and Hypertention are included. |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from systemic disease
2)wound having excessive loss of tissue
3)K/C/O HIV HCV HbSag positive
4)patients having dushta vrana more than 4cm surface area |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the efficacy of Sharad Patra Kashay vranadhawan in Dushta vrana by Reducing Infection pain and swelling of dushta vrana and promote wound healing |
To achieve outcome in 15 days
follow up on 3rd 6th 9th 12th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Find the probable mode of action of sharad patra kashay in dushta vrana.
Reduce Infection pain and swelling of dushta vrana and promote wound healing |
To achieve outcome in 15 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/12/2024 |
| 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="0"
Months="0"
Days="15" |
|
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
|
Dushta Vrana is a common and frequently encountered problem faced in surgical practice the presence of dushta vrana worsen the condition of the patient with different complication and may become fetal local efforts on wound like slough, infection and foreign body affect the normal process of healing A healthy wound in a normal body heals earlier with a minimum scar as compared to contaminated wound therefore in this study all tyhe efforts are made to make a Dushta vrana into Shuddha vrana once the vrana becomes shuddha ropana of the vrana will start, Sharad patra have Antimicrobial Antibacterial action which purifies blood also has vranashodhak and vranaropak properties which is benificial for wound healing |