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CTRI Number  CTRI/2023/09/057596 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 04/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Survey study on skin diseases 
Scientific Title of Study   A Comprehensive Survey Study on the skin Diseases W.S.R. to Viruddha Aahar among the Vadodara 
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 Sariput Bhosikar 
Designation  Professor and HOD 
Affiliation  Parul Institute of Ayurved And Research Parul University  
Address  Room NO 9 Dept of Agadtantra
Parul Institute of Ayurved And Research Parul University PO Ishwarpura Waghodia Vadodara
Vadodara
GUJARAT
391760
India 
Phone  8237705777  
Fax    
Email  drbsariput@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sariput Bhosikar 
Designation  Professor and HOD 
Affiliation  Parul Institute of Ayurved And Research Parul University  
Address  Room NO 9 Dept of Agadtantra
Parul Institute of Ayurved And Research Parul University PO Ishwarpura Waghodia Vadodara
Vadodara
GUJARAT
391760
India 
Phone  8237705777  
Fax    
Email  drbsariput@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harsha E 
Designation  Assistant Professor  
Affiliation  Parul Institute of Ayurved And Research Parul University  
Address  Room NO 9 Dept of Agadtantra
Parul Institute of Ayurved And Research Parul University PO Ishwarpura Waghodia Vadodara
Vadodara
GUJARAT
391760
India 
Phone  7012774630  
Fax    
Email  harshajp1992@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of ayurved and research 
 
Primary Sponsor  
Name  Parul institute of ayurved and research 
Address  parul institute of ayurved and research Parul university Waghodia Vadodara 
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 Sariput Bhosikar  Parul Institute of Ayurved and Research  Room no:9 Dept of Agadtantra Parul Institute of Ayurved and Research
Vadodara
GUJARAT 		 8237705777

drbsariput@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: NOT APPLICABLE, Ritucarya: NOT APPLICABLE, Acara Rasayana:NOT APPLICABLE, Other:NOT APPLICABLE, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having acute and chronic skin diseases 
 
ExclusionCriteria 
Details  patients having diabetes mellitus, hypertension, leprosy, pregnant and lactating mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
quantum of skin diseases caused due to viruddha ahar  180 days 
 
Secondary Outcome  
Outcome  TimePoints 
The patient well being  180 days 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   18/09/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drbsariput@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2025?
    Response (Others) -  one year post publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Viruddha aahara or incompatible food is defined in details in our ancient’s texts. Ahara plays an important role in maintenance of life. Food articles are supposed to maintain a state of equilibrium of doshas , dhatus and malas. Food taken in incorrect form or doses leads to formation of state of no equilibrium giving risk to skin diseases. In the present scenario with the advancement in modern industrialization and increased complexity of society, the frequent trade of international food articles increases the risk of contamination of food articles by the use of biological and chemical preservatives and emerging new combinations of international food with that of native nation.

Need for study:- In present era, due to the change in life style the way of consumption of aahara is also changed this change will leads to manifestation of various types of skin diseases To understand the correlation between viruddha aahara and skin diseases and prevent them by creating an awareness. 

 Material and Methods:-  We will select validated questionnaire on viruddha aahar and by using this questionnaire we will conduct the survey study. The study will conduct on 300 skin disease patients We will select Inclusion criteria as Patients having acute and chronic skin diseases will be selected. Age group -10-70 yr (both the male and female)  Exclusion criteria as Patients having Diabetes mellitus, hypertension, leprosy, pregnant and lactating mothers will be excluded. Observation will be drawn from the survey study Conclusion will be drawn from observation.

 
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