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CTRI Number  CTRI/2024/08/072994 [Registered on: 27/08/2024] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Viruddha Ahara in Rheumatoid Arthritis 
Scientific Title of Study   An Etiopathological Study of Viruddha Ahara and its association to Inflammatory Biomarkers in Rheumatoid Arthritis-A Case Control Study 
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 Mansi Mathur 
Designation  PG SCHOLAR 
Affiliation  All India Institute of Ayurveda 
Address  Room No. 311, 3rd floor,Academic Block, Department of Roga Nidan Evum Vikriti Vigyan, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  09654508872  
Fax    
Email  mansi15mathur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrShalini Rai 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room No. 311, 3rd floor,Academic Block, Department of Roga Nidan Evum Vikriti Vigyan, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  9389423843  
Fax    
Email  vd.raishalini@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrShalini Rai 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room No. 311, 3rd floor,Academic Block, Department of Roga Nidan Evum Vikriti Vigyan, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  9389423843  
Fax    
Email  vd.raishalini@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Sarita Vihar,Gautampuri New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri, Sarita Vihar, New Delhi 110076 
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 Shalini Rai  All India Institute of Ayurveda  OPD no 16, Screening OPD, Hospital Block, Ground floor.
South
DELHI 		 9389423843

vd.raishalini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Division Of Translational Research and Biostatistics Institutional Ethics Comitte All India Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Viruddha Ahara assessment, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients having Age Group 18 to 45 years of both gender, religion and socio – economic status
Newly diagnosed cases of RA as per the 2010 ACR (American College of Rheumatology), EULAR
(European League Against Rheumatism) Criteria for Rheumatoid Arthritis criteria selected from the
OPD /IPD of All India Institute of Ayurveda, New Delhi.
Patient who are taking Anti Inflammatory (Analgesics), steroids, will be included after a washout
period of 7 -14 days
Patients not under any Dietary Regulation. 
 
ExclusionCriteria 
Details  Patient having any other type of Arthropathy such as Neoplasm of Spine, Gout, Ankylosing
Spondylitis etc.
Patient with Chronic Disorder like Paralysis, Cancer, Renal Failure, Hepatic Failure, Cardiac
Disease, Pulmonary Tuberculosis, Diabetes Mellitus type II
Patients suffering from Psychiatric illness.
Pregnant women and lactating mother
Patient taking Antibiotic Therapy for any Systemic Illness within 2 months.
Patients having Severe Crippling Bone Deformity.
Patient who are on disease modifying anti – rheumatoid drugs (DMARDs), and Biologicals are
not included in the Study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To record the "Viruddha Ahara" practices in the patients of R.A and healthy Controls.  1.5 years 
 
Secondary Outcome  
Outcome  TimePoints 
To record the values of AGE, and Hs CRP in the cases and controls,To explore the relationship between the Viruddha Ahara and the biomarker levels in the cases and the controls and to explore the relationship between the Viruddha Ahara and the Disease Activity Scale (DAS 28) in the cases.  1.5 years 
 
Target Sample Size   Total Sample Size="326"
Sample Size from India="326" 
Final Enrollment numbers achieved (Total)= "326"
Final Enrollment numbers achieved (India)="326" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2024 
Date of Study Completion (India) 27/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/11/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In order to assess the Viruddha Ahara dietary practices, a previously developed and validated Questionnaire will be used with due permission, after some modification and revalidation, to include any other parameters and redefine the options of the questions in the format of food frequency questionnaire. The confounders as mentioned will be assessed in both the groups of cases and controls, using suitably drafted questions. Inputs from the experts will be obtained for the validity and the reliability of the same. The scale will be named as Viruddha Ahara Practices Assessment Scale (VAPAS).

Using  validated questionnaire, by an interview process the response of the cases and controls regarding the Viruddha Ahara practices will recorded by  researcher.

The responses will be recorded in a specially prepared format developed for the study.

The disease activity score of the patients will be recorded using DAS – 28 by the researcher.

The subjects from both the groups on the basis of their Viruddha Ahara practices assessment Scale score (VAPASS) will be stratified into two subgroups of High VAPASS and low VAPASS; and random samples of 40 subjects from each of the two strata from the cases and controls, Hence a total of 160 subjects will be analyzed for the levels of the AGE and inflammatory markers.

The data will then be entered in Microsoft excel using appropriate coding and will then be statistically analyzed for any significance as per the research aims and objectives.

 
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