| CTRI Number |
CTRI/2024/11/077030 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of mental factors in causing skin diseases |
|
Scientific Title of Study
|
A Cross-Sectional Study To Evaluate The Role Of Manas Bhavas (Psychological Factors) In Etiopathogenesis Of Skin Diseases. |
| 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 Manpreet Kaur |
| Designation |
PG Scholar |
| Affiliation |
G.J. Patel Institute of Ayurvedic Studies and Research,New Vallabh Vidyanagar, Anand, Gujarat-388120 |
| Address |
Department of Kayachikitsa, OPD number-14, S.G.Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat,India-388120
Anand
GUJARAT
388120
India |
| Phone |
8360431398 |
| Fax |
|
| Email |
manpreet.kaur@ayugjac.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh S Deole |
| Designation |
Professor |
| Affiliation |
G.J. Patel Institute of Ayurvedic Studies and Research,New Vallabh Vidyanagar, Anand, Gujarat-388120 |
| Address |
Department of Kayachikitsa, OPD number-14, S.G.Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat,India-388120
Anand
GUJARAT
388120
India |
| Phone |
9974999309 |
| Fax |
|
| Email |
dryogeshdeole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh S Deole |
| Designation |
Professor |
| Affiliation |
G.J. Patel Institute of Ayurvedic Studies and Research,New Vallabh Vidyanagar, Anand, Gujarat-388120 |
| Address |
Department of Kayachikitsa, OPD number-14, S.G.Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat,India-388120
Anand
GUJARAT
388120
India |
| Phone |
9974999309 |
| Fax |
|
| Email |
dryogeshdeole@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.G.Patel Ayurvedic Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat,India-388120 |
|
|
Primary Sponsor
|
| Name |
Dr Manpreet Kaur |
| Address |
Department of Kayachikitsa, OPD number-14, S.G.Patel Ayurvedic Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat-388120 |
| 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 Manpreet Kaur |
S.G.Patel Ayurveda Hospital and Maternity Home |
Department of Kayachikitsa, OPD number-14, S.G.Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat,India-388120
Anand
GUJARAT |
08360431398
manpreet.kaur@ayugjac.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J. Patel Institute Of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere. Ayurveda Condition: KUSHTHAM, |
|
|
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 |
Patients with all types of skin
diseases (irrespective of gender or
economic status).
Chronicity of skin diseases not more
than one year. |
|
| ExclusionCriteria |
| Details |
Any other serious systemic disorders like
uncontrolled Diabetes mellitus,
hypertension, Immunodeficiency, severe
anemia, jaundice, liver disorders, renal
failure, tuberculosis, cancers, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study would be helpful for physicians to understand role of psychological factors
in skin diseases in ayurvedic perspective. |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A database of dosha specific clinical features of kushtha and their relation with manas
bhava mentioned in classical ayurveda texts can be prepared. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Skin disease is one among the diseases caused by stress. Despite the advancement in the management criteria in the modern era, the prevalence as well
as recurrence of skin disease, is yet escalating. The present study aims to evaluate the role of
manas bhavas (psychological factors) in the development of skin disease, as it may help in management of skin disease
by balancing emotions. This prove to be a good preventive measure. In this study first of all the patient with skin disease will be identified followed by the assessment of stress by applying Holmes-Rahe Stress Rating Scale. After that the involvement of specific psychological factors will be done using Manas Bhava Pariksha Scale. Then the involvement of specific dosha in the skin disease will be analysed using Dosha Specific Assessment Scale in Kushtha. Further the relationship between the specific psychological factor and the dosha involved will be interpreted on basis of the recorded information. This will be helpful to understand role of psychological factors
in skin diseases. Hence avoidance of emotional factors or administration of certain mental therapies may prove to be a good management strategy and may be helpful to prevent
the recurrence of the skin disease. |