| CTRI Number |
CTRI/2025/03/082980 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| 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 Ropan Effect of Dhataki Choorna Avachoornan in management of Shuddha Vrana |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial to evaluate The Ropan effect of Dhataki Choorna Avachoornan in Management of Shuddha Vrana w.s.r.t Non 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 Sanjana Bhalchandra Dama |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department Gadhinglaj Kolhapur Maharashtra Pin code 416502
Late Kedari Redekar Ayurvedic Mahavidyalaya
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9082799284 |
| Fax |
|
| Email |
sanjanadama2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay S Rudrappagol |
| Designation |
HOD at Shalyatantra Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Departure Gadhinglaj Kolhapur Pin code 416502 Maharashtra
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9226150809 |
| Fax |
|
| Email |
drvijayrudrappa@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay S Rudrappagol |
| Designation |
HOD at Shalyatantra Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Departure Gadhinglaj Kolhapur Pin code 416502 Maharashtra
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9226150809 |
| Fax |
|
| Email |
drvijayrudrappa@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra OPD 3 patients Late Kedari Redekar Ayurvedic Mahavidyalaya P2 MIDC Area Shendri Rd Mal Gadhinglaj Maharashtra India Pincode 416501 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjana Bhalchandra Dama |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya P2 MIDC Area Shendri Mal Road Gadhinglaj Kolhapur Maharashtra Pincode 416501 India |
| Type of Sponsor |
Other [] |
|
|
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 Sanjana Bhalchandra Dama |
Late Kedari Redekar Dharmaday Rugnalay Gadhinglaj Kolhapur |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department OPD no 3 P2 MIDC Area Shendri Mal Road Gadhinglaj Kolhapur Maharashtra Pin code 416501 India
Kolhapur
MAHARASHTRA |
9082799284
sanjanadama2@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:T148||Other injury of unspecified body region. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avacUrNan  , अवचूरà¥à¤£à¤¨Â | (Procedure Reference: Sushrut Chikitsasthan Aadhyay 1/72, Procedure details: Vrana prakshalan will be done with normal saline.Dead tissues that are easily visible can excised without much pain and wound will be made dry.Then sufficient amount (up to 5gm) of Dhataki choorna will be dusted. over the wound.After that a sterile dressing pad having sufficient length will be placed over the wound.Proper dressing will be done with sterile bandage cloth.This will be repeated daily for 15 days.)
(1) Medicine Name: Dhataki , Reference: Sushrut sutrasthan 38/45-47, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | avacUrNan  , अवचूरà¥à¤£à¤¨Â | (Procedure Reference: Sushrut Chikitsasthan 1/72, Procedure details: Vrana prakshalan will be done with normal saline.Dead tissues that are easily visible can excised without much pain and wound will be made dry.Then sufficient amount (up to 5gm) of Lodhra choorna will be dusted. over the wound.After that a sterile dressing pad having sufficient length will be placed over the wound.Proper dressing will be done with sterile bandage cloth.This will be repeated daily for 15 days.)
(1) Medicine Name: Lodhra, Reference: Sushrut sutrasthan 38/46, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 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 Shuddha vrana having surface area less than 50cm².
Patient having age between 18 to 50 years.
Patients having wound with the known case of Diabetes, where diabetes is in control.
All open surgical wounds showing Shuddha vrana lakshana |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, Uncontrolled Diabetes any systemic diseases
Patients suffering from wounds like.
Leprotic Ulcers
Malignant Ulcers
Burns
Complex Wounds having excessive loss of Tissues i.e. Wound associated with fracture, ligament tear, tendon rupture. |
|
|
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 |
| To study the Ropan Effect of Dhataki choorna Avachoornan in Shuddha Vrana w.s.r.t Non Infected wound will be assessed by studying clinical presentation pain discharge size |
15 days
On 0, 3rd, 6th, 9th, 12th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Ropan Effect of Dhataki choorna Avachoornan and Lodhra Choorna Avachoornan in Shuddha Vrana
To study Ropan Effect in detail |
On 15th day of study |
|
|
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)
|
01/04/2025 |
| 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 randomised Controlled Clinical Trial to study the efficacy of Dhataki choorna Avachoornan in management of Shuddha vrana with special reference to Non Infected Wound study will be carried in OPD no 3 of Shalyatantra Department of Late Kedari Redekar Ayurvedic Mahavidyalaya and Hospital Gadhinglaj Kolhapur Maharashtra India pin code 416502 .The observations would be drawn on the basis of Reduction of wound Surface area Pain Serous discharge Floor and Granulation of wound on 0th 3rd 6th 9th 12th &15th day respectively and conclusions will be drawn |