| CTRI Number |
CTRI/2024/06/069204 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Viruddha Ahara in Development of Shvitra (Vitiligo) and its association to biomakers - A case control study. |
|
Scientific Title of Study
|
: An Etiopathological Study Of Viruddha Ahara And It’s Association To Biomarkers In Shvitra (Vitiligo) - 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 Anjali Chaudhary |
| Designation |
MD Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 311, 3rd Floor, Academic Block, Department of Roga Nidana Evum Vikriti Vigyan, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
7011139257 |
| Fax |
|
| Email |
anjalijanghu28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Chaudhary |
| Designation |
MD Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 311, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyan, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
DELHI
110076
India |
| Phone |
7011139257 |
| Fax |
|
| Email |
anjalijanghu28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand B More |
| Designation |
Professor Of Roga Nidana Evum Vikriti Vigyan |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 311, 3rd Floor, Academic Block, Department Of Roga Nidana Evum Vikriti Vigyan, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand B More |
All India Institute Of Ayurveda |
Opd No. 16, Screening Opd, Hospital Block, Ground Floor, Gautampuri, New Delhi
South
DELHI |
09422025732
drmoreanand@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. newly diagnosed cases of shvitra(vitiligo).
2. patient having clinical feature of shvitra(vitiligo).
3. healthy individual fulfilling the criteria of swasthya assessment scale. |
|
| ExclusionCriteria |
| Details |
1.Non-cooperative patients.
2.Pregnant and lactating women.
3.Patients suffering from uncontrolled diabetes and hypertension, any other serious systemic disorders like tuberculosis and malignancy.
4.Patients with history of burn and trauma.
5.Patients suffering from Psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Viruddha Ahara practices in the patients of Shvitra (Vitiligo) and healthy controls. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the values of AGE and HsCRP in the cases and controls.
To assess the relation between Viruddha Ahara with level of biomarker in patient of Shvitra
(Vitiligo) and healthy controls.
To assess the relation between Viruddha Ahara and disease severity scale (VETI Score) in
cases of Shvitra (Vitiligo).
To assess the relation between Viruddha Ahara and change in gene expression in the patients
of Shvitra (Vitiligo) and healthy controls. (if possible) |
1.5 YEAR |
|
|
Target Sample Size
|
Total Sample Size="326"
Sample Size from India="326"
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)
|
01/07/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Ayurveda uses the term "Viruddha Ahara" to describe unbalanced meal combinations that can lead to digestive problems, toxic production in the body, and other health related problems. One of the main causes of Shvitra is Viruddha Aahar according to Acharya Charakvii. According to numerous research, Vitiligo is an autoimmune condition. However, the precise causes of this immunological response in healthy persons remain unknown. But, to the best possible knowledge there is limited case control study specifically linking role of Viruddha Ahara as an etiopathological factor in etiopathogenesis of Shvitra (Vitiligo) and in alteration of biomarker in Shvitra (Vitiligo) patients and healthy controls. As a result, a study must be conducted to validate the same. |