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CTRI Number  CTRI/2025/02/081089 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   The role of Wrong Food Combinations (Viruddha Ahara) on Psoriasis, Vitiligo, and Rheumatoid Arthritis and Their Link to Biological Markers- A Case Control Study 
Scientific Title of Study   Assessment of viruddha ahara in autoimmune diseases (plaque psoriasis, vitiligo, and rheumatoid arthritis) and its association with biomarkers (AGE & HsCRP) - 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 Rupashri Nath 
Designation  Assistant Professor 
Affiliation  All India Institute Of Ayurveda, New Delhi 
Address  Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  6398552356  
Fax    
Email  rupashrivapas.24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rupashri Nath 
Designation  Assistant Professor 
Affiliation  All India Institute Of Ayurveda, New Delhi 
Address  Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  6398552356  
Fax    
Email  rupashrivapas.24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalini Rai 
Designation  Associate Professor 
Affiliation  All India Institute Of Ayurveda, New Delhi 
Address  Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, 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, Gautam Puri, Sarita Vihar, New Delhi-110076 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF AYURVEDA 
Address  GAUTAM PURI, 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 Rupashri Nath  All India Institute of Ayurveda  Room No. 306, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyana, All India Institute Of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi-110076
South
DELHI 
6398552356

rupashrivapas.24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DIVISION OF TRANSLATIONAL RESEARCH AND BIOSTATISTICS ALL INDIA INSTITUTE OF AYURVEDA 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. Ayurveda Condition: SVITRAH, (2) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, (3) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  For cases
1. Patients of RA or Plaque psoriasis or vitiligo as per the diagnostic criteria, with chronicity less than 10 years, within the age Group of 21 to 45 years.
2. Patients of either gender, religion, occupation or socio-economic status.
3. Patients willing to participate in the study with written informed consent.


For control
Apparently healthy individuals between the age group of 21 to 45 years, fulfilling the Criteria of Swasthya Assessment Scale and willing to provide written informed consent in the study.
Definitions
Apparently healthy means Individuals have no history of any systemic or infective diseases since the last 1 month, have no complaints of any weakness and demonstrate high working ability.
 
 
ExclusionCriteria 
Details  Patient who are taking anti inflammatory (analgesics), steroids, disease-modifying antirheumatic drugs (dmards), uv therapy, or other potential drugs which may affect the disease outcome and hamper assessment.
2. Patient having any other type of arthropathy such as neoplasm of spine, gout, ankylosing spondylitis, and other existing skin disorder
3. Patient with any other systemic disorders like paralysis, cancer, renal failure, hepatic failure, cardiac disease, tuberculosis, diabetes mellitus, psychiatric illness, hypertension, hypo, and hyperthyroidism.
4. Pregnant women and lactating mothers.
5. Patient taking antibiotic therapy for any systemic illness within 2 months.
6. Patients with crippling bone deformity.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of viruddha ahara practices in autoimmune disease patients (plaque psoriasis, vitiligo, and rheumatoid arthritis) and healthy controls.  1.5 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Characterization of viruddha ahara practices in individuals diagnosed with plaque psoriasis, vitiligo, & rheumatoid arthritis, as well as in healthy controls.
2. Assessment of the impact of viruddha ahara on disease severity scales (pasi, vetf, das28) in plaque psoriasis, vitiligo, & rheumatoid arthritis patients.
3. Evaluation of the impact of viruddha ahara on specific biomarkers (age & hscrp) in autoimmune disease patients compared to healthy controls.
4. Investigation of the correlation between viruddha ahara practices & gene expression patterns in autoimmune disease patients.
5. The effects of viruddha ahara on disease severity scales, biomarkers, & gene expressions in individuals with autoimmune diseases (plaque psoriasis, vitiligo, & rheumatoid arthritis).
 
1.5 YEAR 
 
Target Sample Size   Total Sample Size="558"
Sample Size from India="558" 
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)   15/03/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  
In Ayurvedic texts, different Aacharyas have mentioned that such type of incompatible food combination is origin of various ailments like for example Aacharya Charaka and Aacharya Madhav  have described Viruddha Ahara as cause of Kustha Rogas (skin diseases) and Aamvata (Rheumatoid arthritis).
Various studies have suggested that skin diseases like Plaque Psoriasis, Vitiligo and joint disease like Rheumatoid arthritis are autoimmune disease. But, exact cause of autoimmune diseases is not fully understood. Various factors like genetic predisposition, environmental factors and life style, can play a role in their development. In Ayurveda texts, Nidana Parivarjana is one of the described treatments of diseases. Hence, Nidana Seven may be triggering some factors in body responsible for autoimmune disease pathogenesis. But the specific factors that are triggering this immune response in healthy individuals are still not fully understood. But, to the best possible knowledge there is limited study specifically linking role of Viruddha Ahara in etiopathogenesis of autoimmune disease and role of Viruddha Ahara in alteration of biomarker in diseased patient of autoimmune disease and healthy controls. Hence, it is crucial to conduct research aiming to establish relation between autoimmune diseases and Viruddha Ahara.
The goal of the current study is to asses Viruddha Ahara practices in both healthy controls and patients with three autoimmune diseases that is Plaque psoriasis, Vitiligo, and Rheumatoid arthritis, to observe for any common pattern in the three autoimmune diseases. Additionally, to evaluate how Viruddha Ahara affects gene expression, disease severity scale, and biomarker levels in autoimmune disease patients and healthy controls will also be studied.
 
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