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CTRI Number  CTRI/2019/05/019251 [Registered on: 21/05/2019] Trial Registered Prospectively
Last Modified On: 20/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study To Check If Intake Of Curd Based Incompatible food As A Risk Factor For Vicharchika (A skin Disease) 
Scientific Title of Study   An Observational Study To Identify Risk Factor Of Dadhi Sevanjanya Virudhahar In Vicharchika 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swapnil Rane 
Designation  PG student 
Affiliation  PDEAs College of Ayurved and Research Centre 
Address  PDEAs Ayurved Rugnalaya and Sterling Multispeciality hospital, SECTOR 25, PCNTDA, PUNE
PDEAs College of Ayurved and Research Centre, SECTOR 25, PCNTDA, PUNE
Pune
MAHARASHTRA
411044
India 
Phone  8055533589  
Fax    
Email  swapnil0089.sr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayant J Phadke 
Designation  HOD Agadtantra 
Affiliation  PDEAs College of Ayurved and Research Centre 
Address  PDEAs Ayurved Rugnalaya and Sterling Multispeciality hospital, SECTOR 25, PCNTDA, PUNE

Pune
MAHARASHTRA
411044
India 
Phone    
Fax    
Email  carcagad2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swapnil Rane 
Designation  PG student 
Affiliation  PDEAs College of Ayurved and Research Centre 
Address  PLOT 226, SECTOR 26, PCNTDA, PUNE
PLOT 226, SECTOR 26, PCNTDA, PUNE
Pune
MAHARASHTRA
411044
India 
Phone  8055533589  
Fax    
Email  swapnil0089.sr@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research center 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research center 
Address  PDEAs College of Ayurved and Research center, sector 25, PCNTDA, PUNE 
Type of Sponsor  Private medical college 
 
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 Swapnil Rane  PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital  PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital, Sector 25, PCNTDA, Pune
Pune
MAHARASHTRA 
8055533589

swapnil0089.sr@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: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients Diagnosed As Vicharchika 
 
ExclusionCriteria 
Details  Patients Not Confirmed For Diagnosis of Vicharchika 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify Dadhisevan as a risk factor for Vicharchika  10 mins 
 
Secondary Outcome  
Outcome  TimePoints 
To describe variation of Dadhisevan details of frequency, quantity and pattern as Virudhanapan.
To find the correlation between Dadhi sevanjanya Virudahar and Vicharchika 
10 mins 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   N/A 
Date of First Enrollment (India)   13/06/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Agadtantra, one amongst the eight specialties of Ayurveda; it deals with Vishachikitsa, Vyavahar Ayurveda, Vidhivaidyak. Detailed explanationof types of visha with their gunna, karma, prativisha is mentioned under this subject. Mainly two types of Vishas are explained on the basis of their origin i.e. Stavar (Plant origin) and Jangam (Animal origin). Apart from the types of Stavar and Jaangamvishaa different type of visha is also explained and termed as Dushivisha. This is formed due to indulgence of incompatible food explained under the topic of Virudhahar .

Vicharchika is a common disease of modern day is well explained in Bruhatrayi, all the three samhitakar have mentioned Vicharchika in Kshudrakustha. Amongst its hetus, Virudhahar  is considered as the first and also a major risk factor which leads to dushivisha; thus forming a platform for the samprapti of Vicharchika (च.चि.७/४).

Therefore, to understand and treat Vicharchika it is very essential to have sound knowledge of Agadtantra.

Vicharchika is a very common disease of the modern day. Considering its chronic nature and duration of time required to treat, it is quite strenuous and demanding for the patient in terms of efforts and expenses. Awareness towards prevention of the disease is quite an untouched topic.

Moreover the compilation of such factors would provide with profuse information in respect to the prevention of disease for the risk prone group.

Such an effort to understand and explain the variations and causative factors of one amongst its quotidian risk factor would be a serviceable contribution towards the society.

 
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