| CTRI Number |
CTRI/2024/04/065864 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Blaydi lepa followed by mini punch graft surgery in vitiligo |
|
Scientific Title of Study
|
A Randomized Clinical study to evaluate the efficiency of Balyadi lepa followed by Autologous mini punch graft surgery and Autologous mini punch graft surgery in the management of Shwitra with specific reference to Vitiligo |
| 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 Hemangini Shanabhai Malivad |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved
Department of shalya tantra 4th floor room no 403 Parul University Limbda Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7046392386 |
| Fax |
|
| Email |
hemumalivad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omprakash Dave |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Parul Institute of Ayurved
Department of shalya tantra 4th floor room no 403 Parul University Limbda Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9460770626 |
| Fax |
|
| Email |
dr.omprakashdave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omprakash Dave |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Parul Institute of Ayurved
Department of shalya tantra 4th floor room no 403 Parul University Limbda Waghodia
GUJARAT
391760
India |
| Phone |
9460770626 |
| Fax |
|
| Email |
dr.omprakashdave@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurveda and Hospital, Limbda, Waghodiya, Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Address Parul Institute of Ayurved
Department of shalya tantra 4th floor room no 403 Parul University
Limda
Waghodiya
Vadodara GUJARAT 391760
India |
| 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 Hemangini Shanabhai Malivad |
Parul Institute of Ayurved |
Parul Institute of Ayurved Department of Shalyatantra 4th floor Room no 403 Parul University Limbda Waghodia
Vadodara
GUJARAT |
7046392386
hemumalivad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: yogratnakar kushta chikitsa, Procedure details: GROUP : A
From 1st to 15th day application of balayadi lepa will be applied continuously.
In between 1th and 7th day prachhan karma will be carried out.
16th day Autologous mini punch graft surgery will be done.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Group B: Autologus mini punch graft surgery | Group B:
A)1 Day mini punch graft surgery will be done without applying Balyadi Lepa.
(B)No Prachchan karma will be carried out in this group.
(C)Only modern procedures will be done without any support of ayurved procedures in this group. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1]Patients with single or multiple patches with chronicity of less than 10 years
2]Patches size: 3 to 5 cm long, 3 to 5 cm width
3]In case of multiple lesions 2 lesions of index size will be selected
4]Those who give consent as per requirement |
|
| ExclusionCriteria |
| Details |
1]Systemic diseases like diabetes mellitus HTN
2]Patches on genitals eyes axilla lipsand whole body will be excluded
3]Patients with Bleeding disorders
4]Patients with HIV and HBsAg will be excluded
5]Pregnant women & lactating women keloid tendency |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the Efficacy of balyadi lepa followed by autologous mini punch graft surgery in the management of Shwitra. |
from commencement of treatment in 2 months during procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare effect of balyadi lepa followed by autologus mini punch graft surgery
to study any adverse effect of balyadi lepa followed by autologus mini punch graft surgery
to know the therapeutic effect from all aspects & mode of action combined therapy |
from commencement of balyadi lepa followed autologus mini punch graft surgery in procedure of 2 months & observe effect after complate treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/05/2024 |
| 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
|
| GROUP A – Freshly prepared Balyadi Lepa (Alepa )will be continuously applied from the day 1st till the 15th day of treatment as per the Sushruta Samhita indication for Alepa. At the same time On 1st day and on 07th day Prachhan karma will be done On the 15th day mini punch graft surgery will be planned.
GROUP B – 1st Day mini punch graft surgery will be done without applying Balyadi Lepa No Pracchan karma will be carried out in this group. Only modern procedure will be done without any support of ayurved procedures in this group. | |