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CTRI Number  CTRI/2024/12/078266 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on variations in DLC and ESR in patients of eczema who consume incompatible food 
Scientific Title of Study   Cross Sectional Study On Variations In Differential Leukocytes Count And Erythrocyte Sedimentation Rate In Samyoga Virudha Ahara Janya Vicharchika 
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 Umme Salma 
Designation  MD scholar Roganidana Evum vikruthi vignana  
Affiliation  Government Ayurveda Medical College Bangalore  
Address  OPD 7 Department of Roganidana Government Ayurveda Medical College Dhanwantari road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9845731294  
Fax    
Email  nidhafathi8892@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjitha  
Designation  Associate Professor  
Affiliation  Government Ayurveda Medical College Bangalore  
Address  OPD 7 Department of Roganidana Government Ayurveda Medical College Dhanwantari road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9900411210  
Fax    
Email  drranj.ind@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Umme Salma  
Designation  PG scholar  
Affiliation  Government Ayurveda Medical College Bangalore  
Address  OPD 7 Department of Roganidana Government Ayurveda Medical College Dhanwantari road Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9845731294  
Fax    
Email  nidhafathi8892@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College, Dhanwantari road Bangalore, Karnataka,India 560009 
 
Primary Sponsor  
Name  Dr Umme Salma  
Address  Government Ayurveda Medical College Dhanwantari road Bangalore , Karnataka 560009 
Type of Sponsor  Other [Self] 
 
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 Umme Salma   Government Ayurveda Medical College Bangalore   OPD 7 Department of Roganidana Government Ayurveda Medical College Dhanwantari road Bangalore
Bangalore
KARNATAKA 
9845731294

nidhafathi8892@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient aged 20 to 70 years
Patient of either gender will be selected
Patient who have lakshana of vicharchika
All those vicharchika subjects who have nidana of consuming samyoga virudha ahara  
 
ExclusionCriteria 
Details  1 Patients having kushta other than vicharchika
2 Know case of HIV and HbsAg positive tuberculosis and other systemic infectious diseases
3 know cases of malignancies
4 Pregnant and lactating women

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing the samyoga virudha ahara intake in patient  base line  
 
Secondary Outcome  
Outcome  TimePoints 
observe DLC & ESR in patients who consume samyoga virudha ahara & have vicharchika   base line 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   28/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 ayurveda kushta is a raktapradoshaja vikara.Vicharchika is classified under kshudra kushta it is a kapha[4]/ pittapradhana tridosha kushta vikara characterized by kandu, shyava pidaka, bahusrava, daha, ruk. Though, it is Kshudra Kushtha, it runs a chronic course and has a tendency of exacerbations.
Viruddha Ahara is one potent causative factor for several diseases.Consumption of Viruddha Ahara gives rise to various disturbances of mild to violent nature and produces acute to chronic diseases. samyoga viruddha is a type of viruddha ahara formed by mixing two dravyas of balavatguna which causes vitiation of all the doshas and deha dhatus leading to manifestation of vicharchika.
Nowadays due to changing life styles, urbanization, and fascination with the western culture, there is a noticeable change in food habits and preparatory methods like mixing citrus fruits with milk ,meat and milk products.
Vicharchika is type of eczema and one of the most common skin diseases ,which affects upto 1-3% of adults in most countries of the world .The prevelence rate of eczema in India is 6.75%.
Virudha ahara taken regularly could induce inflammation at a molecular level,disturbing the eicosanoid pathway creating more arachidonic acid leading to increased PG-2 and thromboxane.This inflammatory effect is an important effect as these are all the basic pathologies that create agni mandya ,ama at 
molecular level.
It must be studied that weather such type of samyoga viruddha diet would accelerate antigen and antibody reaction and exhibit an impact on WBC.
These types of studies would also suggest that regular consumption of viruddha ahara would also lead to immunosenescence and chronic inflammation.
DLC measures the percentage of distinct WBCs in blood which increases in response to underlying infection and inflammation and thereby provide valuable information about the immune system .ESR is a measure of inflammation due to underlying chronic disease and infections.These two hematological parameters are accessed in samyoga virudha aharajanya vicharchika.
This study helps in deciding effective pathya in treatment of patient in vicharchika
Hence there a need to evaluate in detail regarding samyoga viruddha in patients with disease of Vicharchika Kusta in order to avoid reoccurrence, reduce progress and intensity of the disease.


 
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