| CTRI Number |
CTRI/2024/04/066062 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the healing properties of Karanja Taila Dressing in Infected Wound |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of Karanja Taila Vikeshika with Chlorhexidine Acetate Dressing in the management of Dushta Vrana(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 Hrishikesh Suresh Patil |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
|
| Address |
OPD No 3 AND IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
7888112394 |
| Fax |
|
| Email |
hrishipatil1908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Jadhav |
| Designation |
M.S (Shalyatantra) |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre |
| Address |
OPD No 3 AND IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9096623998 |
| Fax |
|
| Email |
drmahesh897@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Jadhav |
| Designation |
M.S (Shalyatantra) |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre |
| Address |
OPD No 3 AND IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9096623998 |
| Fax |
|
| Email |
drmahesh897@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Hrishikesh Suresh Patil |
| Address |
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 |
| 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 Hrishikesh Suresh Patil |
Dr D Y Patil College of Ayurved and Research Centre |
OPD No 3 AND IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA |
7888112394
hrishipatil1908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine Acetate Dressing | Chlorhexidine Acetate Dressing will be apply on infected wound | | 2 | 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 Samhita Sutrasthan Chaptyer 18 and Shloka 19, Procedure details: (Procedure Reference: Sushruta Samhita, Procedure details: Vikeshika processed with Karanja Taila will be applied on infected wound.))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Dushta Vrana (Infected Wound) like Srava(slough), Durgandha (Foul Odour), Daha (Burning Sensation), Vedana (Pain), Kandu (Itching). Those who are willing and fulfill 3 out of 5 from these criteria will be included. Dushta Vrana size maximum upto 5cm x 5cm x 1cm (length x breadth x depth ). Patients of controlled Hypertension and Diabetis Milletus on their regular medicines will be included. |
|
| ExclusionCriteria |
| Details |
Patients having diseases like severe septicemia, severe anaemia(Hb less than 8), Uncontrolled Diabetis Milletus. The patients suffering from systemic disease such as Malignancy, Varicose Ulcer , Deep Vein Thrombosis, Arterial Ulcer, Neurogenic Ulcer , Leprosy , Pregnancy, Leukemia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the Shodana (cleansing) effect of Karanja Taila Vikeshika in Dushta Vrana (Infected Wound) .
|
Dressing will be done once in a day for 15 Days. Assessment on 5th ,10th, 15 th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse Effect of Karanja Taila. |
on completion of treatment |
|
|
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)
|
01/05/2024 |
| 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="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
|
A randomized controlled
clinical trial to evaluate the efficacy of karanja taila vikeshika with
chlorhexidine acetate dressing in the management of dushta vrana (infected
wound). To observe the action of karanja taila vikeshika in comparison to the
chlorhexidine acetate dressing in the management of infected wound. Total 60
patients will be enrolled with the sign and symptoms of dushta vrana (infected
wound).30 patients in each group diagnosed with dushta vrana will be treated
with karanja taila vikeshika and other 30 patients with chlorhexidine acetate
dressing for local application. Assessment will be done on 5th , 10th and 15th
day and final conclusion will be drawn on the basis of statistical method. |