| CTRI Number |
CTRI/2025/05/087860 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Examine The Roopan Effect Of Phalinnyadi Choorna in Non Infected Wound |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial to Evaluate the Ropan Effect Of Phalinnyadi 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 |
Vd Vaibhavi Vilas Chavan |
| Designation |
PG Scholer, MS Shalya Tantra |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Post Graduate Research Center, gadhinglaj |
| Address |
Shalya Tantra Department,Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center gadhinglaj,P2 MIDC Area, Shendri Mal, Gadhinglaj, Gadhinglaj
Dist.- kolhapur, Maharashtra
Pin - 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9923982705 |
| Fax |
|
| Email |
vaibhavi2015.vc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vijay S Rudrappagol |
| Designation |
MS.Shalya Tantra, HOD, Shalya Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center gadhinglaj |
| Address |
Shalya Tantra Department,Late Kedari Redekar Ayurvedic Mahavidyalaya, P-2 MIDC Area, Shendri Mal , Gadhinglaj, Gadhinglaj
Dist - Kolhapur,Maharashtra
Pin - 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9226150809 |
| Fax |
|
| Email |
drvijayrudrappa@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vaibhavi Vilas Chavan |
| Designation |
PG Scholer MS Shalya Tantra |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center gadhinglaj |
| Address |
Shalya Tantra Department,Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center gadhinglaj , P2 MIDC Area, Shendri Mal Gadhinglaj , Gadhinglaj
Dist-Kolhapur, Maharashtra
Pin - 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9923982705 |
| Fax |
|
| Email |
vaibhavi2015.vc@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 3 , Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center,gadhinglaj , P2 MIDC Area, Shendri Mal, Gadhinglaj
Kolhapur, Maharashtra, India
Pin -416502 |
|
|
Primary Sponsor
|
| Name |
Vd Vaibhavi Vilas Chavan |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center gadhinglaj, P2 MIDC Area, Shendri Mal, gadhinglaj, kolhapur
Pin - 416502 |
| 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 Vaibhavi Vilas Chavan |
Late Kedari Redekar Ayurvedic Mahavidyalaya and Hospital gadhinglaj |
Shalya Tantra Department,OPD No.3,Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center, gadhinglaj, P2 MIDC Area,Shendri Mal,gadhinglaj, Kolhapur , Maharashtra, India,Pin -416502
Kolhapur
MAHARASHTRA |
9923982705
vaibhavi2015.vc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Research Center gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L988||Other specified disorders 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) | | - | Placentrex gel | 5gm placentrex gel will be applied once daily on wound for 15 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Phalinnyadi choorna , Reference: Charak chikitsa 25/66-67, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of gender, economic class, caste, religion,
Patient having sign and symptoms of shuddha vrana having surface area less than 50 cm2 will be selected
Patients having wound with the known case of Diabetes, where
diabetes is in control or fair control.
All open surgical wound showing sign and symptoms of shuddha vran |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, Uncontroll Diabetes , Any systemic diseases
Patients suffering from wounds like.
Tubercular Ulcers,Venous Ulcers,Leprotic Ulcers, Malignant Ulcers, Burns
Wounds having excessive loss of Tissues i.e.wound include bone,
and tendon injury, exposed bone.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Roopan Effect by Phalinnyadi Choorna |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ropan by Phalinnyadi Choorna More effectively or less effectivly |
15 days |
|
|
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)
|
25/06/2025 |
| 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 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
|
My research study is RCT To Evaluate Ropan Effect Of Phalinnyadi Choorna Avachurnan In shuddh vran w.s.r.t non infected wound, comparative group is placentrex gel and tried drug is Phalinnyadi Choorna 60 patient will be selected randomly according to selection Criteria , from them Phalinnyadi Choorna will applied on 30 patients and placentrex on rest 30 for 15 days daily once , follow up taken on every 3rd day and observations will be recorded according to assessment Criteria , Appropriate Test will be applied to collected data , comparison and Analysis of data will be done and conclusion will be made accordingly |