| CTRI Number |
CTRI/2025/03/083052 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| 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 Efficacy of Yastimadhu Ghrita Parishek in Kshataj Vran |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trail To Study The Efficacy of Yastimadhu Ghrita Parishek in the Management of Kshataj Vran w.s.r. to Lacerated 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 |
DrGururaj Ekanath Alavekar |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj,Kolhapur |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department OPD no.03 Gadhinglaj Kolhapur
pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8698264269 |
| Fax |
|
| Email |
gururaj.alwekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Kadam |
| Designation |
Professor of Shalya Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj,Kolhapur |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department OPD no.03 Gadhinglaj Kolhapur
pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9595353549 |
| Fax |
|
| Email |
drkadamrv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjit Kadam |
| Designation |
Professor of Shalya Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj,Kolhapur |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department OPD no.03 Gadhinglaj Kolhapur
pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9595353549 |
| Fax |
|
| Email |
drkadamrv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD Patients Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department OPD no.03 Gadhinglaj Kolhapur Maharashtra India PIN 416502 |
|
|
Primary Sponsor
|
| Name |
DR Gururaj Ekanath Alavekar |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur Maharashtra India
PIN 416502 |
| 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 Gururaj Ekanath Alavekar |
Late Kedari Redekar Dharmaday Rugnalaya |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department OPD no.03 Gadhinglaj Kolhapur
pin 416502
Kolhapur
MAHARASHTRA |
8698264269
gururaj.alwekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
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: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Yogratnakar uttaradh sadyovran chikitsa adhyay 20/04, Procedure details: Vran prakshalana should be done with normal saline then sufficient amount of Yastimadhu ghrita should be taken in stainless steel bowl and heated on spirit lamp Parishek of koshna yastimadhu ghrita should be poured from a height of 12 Angula means 9 inches approximately from the body part This Procedure Should be carried out for 2 to 3 minutes daily once in the morning for 15 days During Procedure Ghrita Should be reused by reheating Sterile Pad should be used to cover the wound and dressing will be done with sterile bandage)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone iodine | The sufficient amount of Povidone iodine solution application should be done over the wound after that a sterile dressing pad having sufficient length & breadth to cover the wound should be taken and placed over that Proper dressing should be done with sterile bandage this should be repeated daily for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of kshataj vrana having size which is less than 5 cm x 5 cm in length & max depth up to dermis (approx) be randomly selected |
|
| ExclusionCriteria |
| Details |
Known cases of HIV HepatitisB TB any systemic disease like DM patients having bleeding disorders Tubercular Ulcers venous ulcer leprotic ulcer malignant ulcer Burns Wounds having excessive loss of Tissues and tendon injury exposed bone Picchita Vrana Vidhha Vrana Complex wound like wound associated with fracture ligament tear tendon rupture wound with profuse continuous bleeding which needs surgical hemostasis |
|
|
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 |
| Relief from pain and burning sensation |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from pain burning sensation and ropan effect of Kshataj Vrana |
15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/04/2025 |
| 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
|
This study is a randomized controlled clinical trial to study the efficacy of yashtimadhu ghrita parishek in the management of kshataj vran w.s.r to lacerated wound. Study will be carried in OPD of shalayatantra department of Late kedari redekar ayurvedic mahavidyalaya and hospital Gadhinglaj. The observation would be drawn on the basis of symptoms after treatment given |