| CTRI Number |
CTRI/2021/02/030941 [Registered on: 02/02/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
An observation study to see the effect of incompatible diet in development of shvitra(vitiligo) |
|
Scientific Title of Study
|
Evaluating classical etiopathogenesis of Shvitra (Vitiligo) in current era in relation to Prakriti and Biochemical Markers-A case control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Mishra |
| Designation |
P G scholar |
| Affiliation |
All India institute of Ayurveda |
| Address |
Rog nidana avum vikriti vigyan department,acedemic block,third floor, All India insttiue of ayurveda,gautam puri,sarita vihar new delhi
110095
South DELHI 110095 India |
| Phone |
9267994251 |
| Fax |
|
| Email |
mishrapriyanka22793@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anand more |
| Designation |
Professor |
| Affiliation |
All India institute of Ayurveda |
| Address |
Rog nidana avum vikriti vigyan department,acedemic block,third floor, All India insttiue of ayurveda,gautam puri,sarita vihar new delhi
110095
South DELHI 110095 India |
| Phone |
8830389544 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anand more |
| Designation |
Professor |
| Affiliation |
All India institute of Ayurveda |
| Address |
Rog nidana avum vikriti vigyan department,acedemic block,third floor, All India insttiue of ayurveda,gautam puri,sarita vihar new delhi
110095
South DELHI 110095 India |
| Phone |
8830389544 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Ayurveda,gautampuri,sarita vihar,new delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India institute of Ayurveda |
| Address |
Gautampuri,sarita vihar,new delhi |
| 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 Priyanka Mishra |
Hospital block All India institute of Ayurveda |
OPD NO.5,Hospital block
ground floor,all india institute of ayurveda gautampuri,sarita vihar,south
new delhi South DELHI |
9267994251
mishrapriyanka22793@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient presenting with symptoms of SHVITRA (vitiligo) will included in this study.
2.Patient will be randomly selected irrespective of sex, age, religion, occupation, and economic status after due processed of informed consent.
3. Patient will be randomly selected irrespective of origin, site, size of patches.
4.Patients between the age group of 10 to 60 years.
5.Less than 1-3 year diagnosed case.
|
|
| ExclusionCriteria |
| Details |
1.Noncooperative and immunosuppressive patient.
2.Patient below 10year and above 60 year.
3.Pregnent women.
4.Patient with history of burn and trauma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To prepare preventive protocol for SHVITRA (vitiligo).
,To identify which prakriti is more prone to develop SHVITRA (vitiligo)
, To identify biochemical markers (based on rakta dusti and virudha aahara) in pt. of SHVITRA.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o prepare preventive protocol for SHVITRA (vitiligo).
,To identify which prakriti is more prone to develop SHVITRA (vitiligo)
,To identify biochemical markers (based on rakta dusti and virudha aahara) in pt. of SHVITRA.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
28/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Article will be published later in the reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In
Ayurveda skin diseases are considered in the umbrella of kustha. Kustha is the term
given to the group of symptoms accrued in the skin disease. Kustha which are
further divided into maha and kshudra kustha, however SHVITRA has not
been counted among various type of kustha in brihatrayi later on this has been
included under type of kustha but difference between SHVITRA and kustha
is based on non-secretary,non-infectious, involvement of twaka ,peculiarity of
nidana, asadhya lakshana and chronicity. According to Modern dermatology, SHVITRA
can be incorporated into broad heading of leukoderma/vitiligo of unknown aetiology
even today. On the face is ranked 17th by W.H.O. in world’s most
disabling (mentally and socially) disease. In Ayurveda no separate
description on aetiology is available of SHVITRA, but general aetiology
of kustha is to be taken under consideration to understand the etiopathogenesis
of the disease. Main reason behind SHVITRA based on Ayurveda
pathophysiology is consider due to indulgence of a person in the injudicious
dietetics, habit, virudha ahara vihara. It has been widely accepted by all the authors.
Acharya charaka has listed the SHVITRA under Rakta pradoshaja vikaar. According to Asthang Hridya and Asthang Sangraha
increased intake of kaphaj aahar-vihaar by mother during pregnancy may lead to
appearance of SHVITRA. In Pauranik kala Manusmriti has
contraindicated ten families including SHVITRA affected family for marriage,
above all factor could be genetic predisposing of SHVITRA (M.N.3). So,
from various Ayurvedic literature Rakta dusti and virudha ahara- vihara, maternal
habit of food and life style (during pregnancy) can consider as a causative
factor of SHVITRA, but definite cause and aetiology is still unknown. From modern point of view, vitiligo can be
treated by many numbers of ways like therapy and surgery but exact aetiology is
still unknown. Even
VRF (vitiligo research foundation, America) is still working on exact aetiology
of vitiligo. In
Ayurveda we have to certainly need to generate a sufficient evidence base for
pathogenesis of SHVITRA with help of modern science,technologies,and
experimental rigours in order for it to gain under global acceptance.Indentification
of biochemical marker, could lead to new approach to the prevention and
evidence based preventive protocol for SHVITRA,
relation of prakriti assessment also undertaken to consolidate the evidence of
such association which exits between Prakriti, Rakta dusti, ahara vihara and manasa
nidana of SHVITRA. The Constituent of prakriti present a set of
metabolic tendencies, which may be contribute as a trigger factor when combined
with factor like environmental, diet, lifestyle in development of SHVITRA. |