| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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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