| 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 |
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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 |
|
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Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
GAUTAM PURI, SARITA VIHAR, NEW DELHI- 110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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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 |
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Regulatory Clearance Status from DCGI
|
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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, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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
|
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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. |