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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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

 
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