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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
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 severe”.

 
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