| CTRI Number |
CTRI/2025/02/079935 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to determine milk incompatibility in commonly used food preparations in manifestation of skin disease (eczema) |
|
Scientific Title of Study
|
A case control study to Evaluate the role of Samyoga Viruddha of milk in commonly used food preparation of North India as a risk factor in development of Vicarcika (Eczema) |
| 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 Namrita |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 204 Department of Samhita and Siddhanta Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
6239493358 |
| Fax |
|
| Email |
namrita6239@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Bishnoi |
| Designation |
Assosiate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 204 Department of Samhita and Siddhanta Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9784526652 |
| Fax |
|
| Email |
ashokb47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrita |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 204 Department of Samhita and Siddhanta Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
6239493358 |
| Fax |
|
| Email |
namrita6239@gmail.com |
|
|
Source of Monetary or Material Support
|
| Screening OPD of Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh pincode 160047 India |
|
|
Primary Sponsor
|
| Name |
Dr Namrita |
| Address |
A 204 Department of Samhita and Siddhanta
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh |
| 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 Namrita |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh |
204
Department of Samhita and Siddhant
Chandigarh
CHANDIGARH |
6239493358
namrita6239@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
For case group-
1. Patient of 18 to 60 years of all gender.
2. Patient diagnosed with Vicarcika.
3. Patient who are from north India.
4. Patient who are willing to participate in the trial.
5. Patients who are taking Viruddha Ahara related to milk.
For control group-
1. Subject age of 18 to 60 years of all gender.
2. Subject without skin disorder.
3. Subject who are from north India.
4. Subject who are willing to participate in the trial.
5. Subject who are taking Viruddha Ahara related to milk. |
|
| ExclusionCriteria |
| Details |
For case group
1. Patient below 18 years and above 60 years.
2. Patient with CKD and H3 viral marker profile test positive.
3. Patient who are not from north India.
4. Patient who are not willing to participate in the trial.
For control group-
1. Subject below 18 years and above 60 years.
2. Subject with other systemic diseases.
3. Subject who are not from north India.
4. Subject who are not willing to participate in the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To conduct a survey study on patients of Vicarcika (Eczema) and impact of their food consumption habits related to milk combination. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the influence of incompatible milk combinations on manifestation of Vicarcika (Eczema).
To understand the frequency of incompatible milk combination impacting on
Vicarcika (Eczema).
To find out different foods or ingredients combined with milk and reported adverse reactions or discomfort associated with specific milk combinations. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
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)
|
15/02/2025 |
| 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 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
|
Abstract: Nutrition is the fundamental element necessary for the maintenance of life for all organism. It is the important factor in the attainment of good health. With unhealthy eating habits being a contributing factor to disease. Consuming healthy food not only supports proper digestion, but also enhances mental and physical strength. The study of now food interacts with other foods is a developing field in the present time. The combination, preparation methods and timing of consuming food can alter its properties and subsequently affect the benefits derived from it.
Aim: To conduct a survey study on patients of Vicarcika (Eczema) and impact of their food consumption habits related to milk combination.
Objectives: To study the influence of incompatible milk combinations on manifestation of Vicarcika (Eczema). To understand the frequency of incompatible milk combination impacting on Vicarcika (Eczema). To find out different foods or ingredients combined with milk and reported adverse reactions or discomfort associated with specific milk combinations.
Material and Methods: The minimum no. of 152 patients of diagnosed Vicarcika (Eczema) and 152 healthy volunteer will be enrolled from the screening OPD of Shri Dhanwantry Ayurvedic Medical College & Hospital, Sector 46B, Chandigarh. The dietary regime of milk of the patient will be assessed based on pre-designed questionnaires. The questionnaire will include information about daily routine and milk dietary history of the patient. Questionnaire will be prepared from Brhat-trayi and it will be closed ended. |