| CTRI Number |
CTRI/2024/11/077292 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of vranaropankar churna in the treatment of suddha vrana |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the ropan effect of vranaropankar churna local application in the management of shuddha vrana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umesh Abhiman Paikrao |
| Designation |
PG scholar MS Shalyatantra |
| Affiliation |
MES Ayurveda Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9860732383 |
| Fax |
|
| Email |
umeshpaikrao9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Pawar |
| Designation |
Associate Professor MS Shalyatantra |
| Affiliation |
MES Ayurveda Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Umesh Abhiman Paikrao |
| Designation |
PG scholar MS Shalyatantra |
| Affiliation |
MES Ayurveda Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9860732383 |
| Fax |
|
| Email |
umeshpaikrao9@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722 |
|
|
Primary Sponsor
|
| Name |
Dr.Umesh Abhiman Paikrao |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri,Maharashtra, India-415722 |
| 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 Umesh Abhiman Paikrao |
Parshuram Hospital And Research center |
Shalyatantra OPD,Ghanekhunt Lote, Khed Ratnagiri MAHARASHTRA
Ratnagiri
MAHARASHTRA |
09860732383
umeshpaikrao9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved Mahavidyalaya Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vranaropankar churna, Reference: Charak Chikitsa sthana 25/67, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: dressing of wound will be on alternate day by vranaropankar churna | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Jatyadi Tail, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: dressing will be on alternate days by jatyadi tail for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having vrana in shudha awastha.2) Patients having wound with depth less than 1cm.3) Patients irrespective of sex, religion, occupation etc4) Dimension of wound up to 30sq.cm.5)Patients either Age between 18 to 60 years.6)Patients having wounds on extremities only |
|
| ExclusionCriteria |
| Details |
1)Wounds which are dushta.2)Patients having bleeding disorder3) Wounds of size more than 30sq.cm.4) known case of AIDS, DM, Hepatitis B., TB and immunocompromised people5) Patient having wound with depth more than 1cm. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Vranaropankar Churna in the treatment of shuddha vrana after 15days |
15 days study with alternate day dressing and follow up and wound assessment will be done on 0th,5th,10th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the ropan effect of vranaropankar churna after 15 days of of intervention |
15 days study with alternate day dressing & wound assessment will be done on 0th,5th,10th & 15th day |
|
|
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)
|
03/12/2024 |
| 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="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
|
TITLE- A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE ROPANEFFECT OF VRANAROPANKAR CHURNA LOCAL APPLICATION IN THE MANAGEMENT OF SHUDDHA VRANANull Hypothesis: Vranaropankar Churna is not significantly effective for ropan karma of Shuddha Vrana.
Alternate Hypothesis: Vranaropankar Churna is significantly effective for the ropan karma of Shuddha Vrana.
Study Design: Simple Randomized Controlled Clinical Trial
Inclusion Criteria : 1) Patients having vrana in shudha awastha. 2) Patients having wound with depth less than 1cm. 3) Patients irrespective of sex, religion, occupation etc 4) Dimension of wound up to 30sq.cm. 5)Patients either Age between 18 to 60 years. 6)Patients having wounds on extremities only
Exclusion Criteria: 1)Wounds which are dushta. 2)Patients having bleeding disorder 3) Wounds of size more than 30sq.cm. 4) known case of AIDS, DM, Hepatitis B., TB and immunocompromised people 5) Patient having wound with depth more than 1cm.
Sample Size: Total 70 (35 for each group)
Patients coming in OPD and IPD of Shalyatantra department of our hospital with complaints of shuddha vrana. Simple randomized sampling (Lottery Method).
Group A: Vranaropankar Churna Group B: Jatyadi Tail
15 days of study with alternate day dressing
Follow Up And Wound Assessment: Alternate day follow up and wound assessment will be done on 0th,5th,10th and 15th day.
Result:- Result will be drawn as per assessment criteria & statistical analysis.
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