| CTRI Number |
CTRI/2024/02/062917 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study to understand the influences Of psychological factors in Psoriatic patients |
|
Scientific Title of Study
|
An Observational study to assess the relationship between Manasa Prakruthi in manifestation Of Kitibha Kushta with special reference to Psoriasis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Tiwari |
| Designation |
Student |
| Affiliation |
Guru Gorakshnath Institute Of Medical Sciences Faculty Of Ayurveda |
| Address |
Guru Gorakshnath Institute Of Medical Sciences Faculty Of Ayurveda Arogya Dham Balapar Road Sonbarsa Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
6394005789 |
| Fax |
|
| Email |
simran2611ac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya S R Nair |
| Designation |
Assistant Professor |
| Affiliation |
Guru Gorakshnath Institute Of Medical Sciences Faculty Of Ayurveda |
| Address |
Guru Gorakshnath Institute Of Medical Sciences Faculty Of Ayurveda Arogya Dham Balapar Road Sonbarsa Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
8281983814 |
| Fax |
|
| Email |
drpriyanair@mgug.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya S R Nair |
| Designation |
Assistant Professor |
| Affiliation |
Guru Gorakshnath Institute Of Medical Sciences Faculty Of Ayurveda |
| Address |
Guru Gorakshnath Institute Of Medical Sciences Faculty Of Ayurveda Arogya Dham Balapar Road Sonbarsa Gorakhpur Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
8281983814 |
| Fax |
|
| Email |
drpriyanair@mgug.ac.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences
Jawaharlal Nehru Bhartiya Chikitsaevam Homeopathy Anusandhan Bhavan Institutional Area Opp D Block Janakpuri New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council of Research in Ayurvedic Sciences |
| Address |
Jawaharlal Nehru Bhartiya Chikitsaevam Homeopathy Anusandhan Bhavan Institutional Area Opp D Block Janakpuri New Delhi 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Priya S R Nair |
Guru Gorakshnath Institute of Medical Sciences Faculty of Ayurveda |
Department of Kriya Sharir
Third floor
Arogya Dham Balapar Road Sonbarsa Gorakhpur
Gorakhpur
UTTAR PRADESH |
8281983814
drpriyanair@mgug.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Studies Guru Gorakshnath Institute of Medical Sciences Faculty of Ayurveda Arogya Dham Balapar Road Sonbarsa Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
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 |
Pre Diagnosed Cases Of Psoriasis
Confirmed By PASI Scale
Psoriasis Should Be Primary Disorder |
|
| ExclusionCriteria |
| Details |
Psoriasis Will Be Secondary Disorder
Multiple Organ Affected Disorder
Developmental Delay
History Of Chromosomal Anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study can help the medical profession to know the vulnerability of Satwa, Raja, and Tama Pradan Manasa Prakruthi towards Psoriasis.
The present study provides an updated quantification of the growing public health burden of psoriasis in assessing area.
This kind of study would further help in prevention of progression of the psoriasis.
|
at baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
26/02/2024 |
| 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="0"
Months="2"
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
|
This study is an
observational single armed study to assess the relationship between Manasa
Prakruthi in manifestation of Kitibha Kishta with special reference to
Psoriasis by fulfilling PASI scale of age group 18-60 years. This study can help the medical profession to know the vulnerability of Satwa, Raja, and Tama Pradan Manasa Prakruthi towards
Psoriasis.It provides an updated quantification of the growing public
health burden of psoriasis in assessing area.This kind of study would further help in prevention of
progression of the psoriasis. |