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CTRI Number  CTRI/2024/09/074358 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Development Of Standardized Scale For The Assessment Of Sattva Pariksha In Healthy Subjects  
Scientific Title of Study   A Cross Sectional Survey Study To Develop A Scale For The Assessment Of Sattva Pariksha In Healthy Subjects. 
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 RAKSHITHA K T 
Designation  PG Scholar Department Of Ayurveda Samhita And Siddhanta 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India 
Phone  6362194975  
Fax    
Email  rakshithakt98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAJA RAJESHWARI N M 
Designation  PROFESSOR Department Of Ayurveda Samhita And Siddhanta 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India 
Phone  9964586059  
Fax    
Email  drrajarajeshwari@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  DR RAJA RAJESHWARI N M 
Designation  PROFESSOR Department Of Ayurveda Samhita And Siddhanta 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India 
Phone  9964586059  
Fax    
Email  drrajarajeshwari@sdmcahhassan.org  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, Hassan  
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 RAKSHITHA K T  Room No 8A ,KC fever opd.  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL THANNIRUHALLA, HASSAN, 573201 ph- 08172-256460, 9448064277
Hassan
KARNATAKA 		 6362194975

rakshithakt98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Hassan BM Road Thanniruhalla Hassan-573201 Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  subjects who do not have any medical condition 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects of all gender
Subjects willing to give consent
Subjects between the age group 18 to 40years
 
 
ExclusionCriteria 
Details  Subjects with any known illness or mentally unsoundedness.
Subjects incapable to give valid responses
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop a questionnaire to assess the sattva as a component of quality of life as per ayurveda in healthy subjects  6 months 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/01/2025 
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  

TITLE OF THE STUDY – A CROSS SECTIONAL SURVEY STUDY TO DEVELOP A SCALE FOR THE ASSESSMENT OF SATTVA PARIKSHA IN HEALTHY SUBJECTS.

 

SUMMARY:

Mental health is the absence of mental illness viz., depression, anxiety etc which doesn’t imply that an individual is mentally sound. Mental strength gives the ability to tolerate discomfort and take conservative, courageous action. Ayurveda has given importance not only to physical wellbeing but also to psychological wellbeing. Majority of the scales presently available are from contemporary science designed to assess the state of specific clinical conditions rather on psychological wellbeing. Sattva Pariksha explained includes the assessment of state of mind. by considering various components like their behavior, nature, attitude and their involvement in activities which can be used for the assessment of psychological wellbeing. But the Lakshana used in Sattva pariksha is open to multiple interpretations. Thus this study is aimed at development of a standardized tool for the assessment of Sattva based on the parameters given in Sattva Pariksha.

OBJECTIVE

1.     To study the concept of Sattva in detail.

2.     To develop a scale for the assessment of Sattva in healthy individuals.

METHODOLOGY

SOURCE OF DATA:

·       Literary Data: All the relevant data about sattva are collected from relevant ayurveda texts and contemporary journals.

·       Survey Study:

Subjects who fulfill the inclusion criteria would be selected from  of Sri Dharmasthala Manjunateshwara College of Ayurveda and Hospital, Hassan, Karnataka.

METHOD OF COLLECTION OF DATA:

     Study Type:  Survey study.

    Time perspective: Cross sectional.

    Method of sampling:Convenience sampling

     Sample size: 400

INCLUSION CRITERIA:

1.     Subjects of both gender

2.     Apparently Healthy individuals.

3.     Subjects willing to give consent.

4.     Subjects between the age group 18-40 years.

EXCLUSION CRITERIA:

1.     Subjects with any known illness or mentally unsoundness.

2.     Subjects incapable to give valid responses.

 
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