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CTRI Number  CTRI/2023/04/051368 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 23/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Screening of the Incompatible diet and dietary intake irregularities in Rheumatoid Arthritis 
Scientific Title of Study   Screening of the Viruddha Ahara (Incompatible diet) consumption and dietary intake (Ahara vidhi) irregularities in cases of Amavata(Rheumatoid Arthritis) A Retrospective 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 Kiran Maurya 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Department of Kayachikitsa State Ayurvedic College and Hospital Lucknow U P 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9455226962  
Fax    
Email  maurya790kiran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Rastogi 
Designation  Associate Professor 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Department of Kayachikitsa State Ayurvedic College and Hospital Lucknow U P 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415022955  
Fax    
Email  rastogisanjeev@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kiran Maurya 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Department of Kayachikitsa State Ayurvedic College and Hospital Lucknow U P 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9455226962  
Fax    
Email  maurya790kiran@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital, Lucknow  
 
Primary Sponsor  
Name  Dr Kiran Maurya 
Address  Department of Kayachikitsa State Ayurvedic College and Hospital Lucknow UP  
Type of Sponsor  Other [Individual ] 
 
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 Kiran Maurya  Ayurveda - Arthritis Treatment and Advanced Research Centre SAC & H Lucknow  Department of Kayachikitsa State Ayurvedic College & Hospital Lucknow 226003
Lucknow
UTTAR PRADESH 		 9455226962

maurya790kiran@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: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Amavata patients having a simultaneous diagnosis of RA and a history of less than 3 years
2 Patients having no co existing illness having a possibility to affect the dietary likings and intake pattern.
3 Patient having no other co-existing joint disease.
4 Patients not having any history of alcohol intake, smoking or tobacco chewing.
5 Patients willing to participate in the study
 
 
ExclusionCriteria 
Details  1 Cases of Amavata /RA having a history of more than 3 years
2 Age – less than 25 and more than 50 years
3 Patients having co existing illness having a possibility to affect the dietary likings and intake pattern (To be excluded through investigations like CBC, RBS, TSH, & KFT, LFT).
4 Patient having other co-existing joint disease
5 Patients of RA requiring urgent care.
6 Patient having a recent history of alcohol intake, smoking or Tobacco chewing
7 Patients not willing to participate in the study
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Availability of various components of viruddha ahara in terms of their frequency in the referred population (case & control).
2. Quantitative assessment of various viruddha ahara components in terms of intake frequency (FFQ) in respective population.
3. Assessment of various component of viruddha ahara in terms of total duration of consumption.
4. Assessment of common irregularities of dietary intake methods in terms of their frequency & chronicity in respective population.
5. Assessment of relative risk factors & odds ratio in reference to various components of viruddha ahara and dietary irregularities.
 		 Viruddha ahara % in reffered population - 3 months
Viruddha ahara quantitative assessment - 4 months
Viruddha ahara duration assessment - 5 months
Dietary irregularity assessment - 6 months
Relative risk factor assessment - 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in life style  6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/05/2023 
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="3"
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [maurya790kiran@gmail.com].

  6. For how long will this data be available start date provided 01-05-2023 and end date provided 01-03-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To identify the association of viruddha ahara and erratic dietary practices with Amavata/RA through a retrospective observational study and  to explore the textual  concept of viruddha ahara and  dietary intake irregularities  in the contemporary context.
To develop a validated food frequency  and food intake method based questionnaire to identify the viruddha ahara and  dietary intake irregularities in the study population  
Assessment of association of VA with amavata in cases having amavata and controls not having amavata.
Based upon the observations, proposal of diet based intervention plan for effective prevention and management of amavata can be given.

 
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