| CTRI Number |
CTRI/2024/07/071301 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Single Group Survey Study to Assess Psychological Symptoms in Patients of Kushta ( Skin Disorders) |
|
Scientific Title of Study
|
An Observational Study on Psychological Assessment in Kushta |
| 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 Sarang Subrahmanyan |
| Designation |
PG Scholar, Department of Manovigyan avum Manasa Roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Manovigyan avum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Tanniruhalla , Hassan , Karnataka
Hassan KARNATAKA 573201 India |
| Phone |
7012545291 |
| Fax |
|
| Email |
pg22138@sdmcahhassan.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tapas Brata Tripathy |
| Designation |
Professor and Head ,Department of Manovigyan avum Manasa Roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Manovigyan avum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Tanniruhalla , Hassan , Karnataka
Hassan KARNATAKA 573201 India |
| Phone |
9448705599 |
| Fax |
|
| Email |
drtbtripaty@sdmcahhassan.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Tapas Brata Tripathy |
| Designation |
Professor and Head ,Department of Manovigyan avum Manasa Roga |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Department of Manovigyan avum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Tanniruhalla , Hassan , Karnataka
Hassan KARNATAKA 573201 India |
| Phone |
9448705599 |
| Fax |
|
| Email |
drtbtripaty@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital , BM Road Tanniruhalla , Hassan 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Tanniruhalla Hassan 573201 |
| Type of Sponsor |
Private medical college |
|
|
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 Sarang Subrahmanyan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Department of Kayachikitsa ( Twak Roga)
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Tanniruhalla Hassan 573201 Hassan KARNATAKA |
7012545291
pg22138@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. 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 |
1. Participants suffering from any type of Kushta.
2. Age group of 18-60 years.
3. Subjects willing to sign informed consent and participate
|
|
| ExclusionCriteria |
| Details |
1. Diagnosed cases of any Psychiatric Illness
2. Subjects with cognitive impairment.
3. Subjects suffering from Sheetapitta, Udarda, Kota.
4. Subjects under the influence of psychoactive substances at the time of assessment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishing the Involvement of Psychological Symptoms in Kushta. |
20 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Establishing the involvement of Psychological Symptoms in the exacerbation of Kushta |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="101" Sample Size from India="101"
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)
|
28/07/2024 |
| 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="1" Months="0" 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 is a First of a Kind Study in Ayurveda aimed at assessing the psychological symptoms in Kushta. About 30 percent of patients who have skin disorders are reported to have psychological manifestations and psychosocial impairments such as feelings of stress, anxiety, anger, depression, shame, social isolation, low self-esteem, and embarrassment. These factors are often not looked upon or are neglected when it comes to the interventional aspect. Psychological assessment in the patients of Kushta can provide a route map towards prevention from further worsening of disease, planning effective interventions and to predict prognosis of the disease. The Severity of the Psychological symptoms involved in a skin disease needs more exploration and this assessment paves a new way into a clinician’s approach towards a dermatological condition. Here, Psychological Assessment is done using DASS-21 Scale. SURVEY METHOD: Questionnaire-
based
· A pre-validated questionnaire DASS-21 (Depression, Anxiety and Stress Scale) Questionnaire will be used for this study to
collect qualitative data
· A questionnaire would be filled out by
the researcher.
· The responses will be recorded and
results will be analyzed with the help of a statistical tool based on the
results and conclusions will be drawn.
Each Diagnosed participant who are willing to sign the
informed consent would undergo psychological assessment using DASS-21(Depression,
Anxiety and Stress Scale) Questionnaire.
DASS-21 is a health tool that evaluates the severity
of behavioral and emotional symptoms that are correlated with depression,
anxiety disorder and stress.
Each of the three DASS-21 scales contains 7 items, divided
into subscales with similar content. The depression scale assesses dysphoria,
hopelessness, devaluation of life, self-depreciation, lack of interest /
involvement, anhedonia and inertia. The anxiety scale assesses autonomic
arousal, skeletal muscle effects, situational anxiety, and subjective
experience of anxious affect. The stress scale is sensitive to levels of
chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal,
and being easily upset / agitated, irritable / over-reactive and impatient.
Scores for depression, anxiety and stress are calculated by summing the scores
for the relevant items.
The 21 items on the questionnaire
comprise a set of 3 self-reported scales designed to assess DASS. The 7
elements on the scales are graded on a Likert scale from 0 to 3 (0: Does not
apply to me at all, 1: Applied to me to some degree or some of the time, 2:
Applied to me to a considerable degree or a good part of the time and 3:
Applied to me very much or most of the time). Depression, anxiety, and stress
scores are measured by summarizing the scores of the related items.
Because the DASS-21 is a shorter version of the
42-item original DASS, the score for each subscale must be multiplied by 2 to
calculate the final score. According to the manual, the resulting ratings then
are classified as: “normal, mild, moderate, severe, or extremely severeâ€. |