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CTRI Number  CTRI/2025/03/083447 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Other 
Public Title of Study   Development and Validation of a Questionnaire to measure mental strength 
Scientific Title of Study   Development and Validation of a Questionnaire to Assess Satvasara (Mental Strength) - A Descriptive Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kajal 
Designation  MD Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  PG Department of Kriya Sharir, Chaudhary Brahm Prakash Ayurved Charak Sansthan, khera dabar, New Delhi

South West
DELHI
110073
India 
Phone  8470998451  
Fax    
Email  kajaldahiya114@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Prakash 
Designation  Assistant Professor, PG Department of Kriya Sharir 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  PG Department of Kriya Sharir, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi

South West
DELHI
110073
India 
Phone  9818180526  
Fax    
Email  drshaliniprakash007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalini Prakash 
Designation  Assistant Professor, PG Department of Kriya Sharir 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  PG Department of Kriya Sharir, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi

South West
DELHI
110073
India 
Phone  9818180526  
Fax    
Email  drshaliniprakash007@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Kriya Sharir, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi- 110073, India 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi- 110073 
Type of Sponsor  Government 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 Kajal  Ch. Brahm Prakash Ayurved Charak Sansthan  PG Department of Kriya Sharir, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi- 110073
South West
DELHI 
8470998451

kajaldahiya114@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently Healthy Individuals 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1. Self-declared apparently healthy subjects aged 18-30 years.
2. Individuals who have no history of any acute or chronic illness which may impact mental health of the individual.
3. Individual willing and able to participate in the study. 
 
ExclusionCriteria 
Details  1. Individuals having history of any psychological/psychiatric disorder.
2. Individuals who are on any kind of medication.
3. Individuals who underwent counseling by the psychologist. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Development of standardized questionnaire for the assessment pf Satvasara.
2. Validation of Satvasara questionnaire. 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   20/08/2025 
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="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  

INTRODUCTION

Ayurveda is the science of life. It describes life as the complex combination of Sharir (body), Indriya (senses), Satva (mind), and Atma (soul).  This signifies the role of Manas in the maintenance of health. Acharya Sushrut has described health as physical health as well as mental health.  Raja and Tama, these are the two manas doshas. Pragyaaparadh  has a role in the manifestation of physical and mental disorders. Pragyaparadh occurs due to vitiation of Raja and Tama Dosha. Satva Guna enhancement is one of the most important things to be focused on during treatment.

Mental well-being is defined as a state of mind where an individual can develop their potential& work productively, and cope with the normal stresses of life. Psychological well-being is considered crucial for comprehensive health and happiness and has been linked to improved mental health, better physical health, and a longer life expectancy.

Mental health plays a major role in proper digestion of food. Acharya Charak has emphasized the role of mindful eating under Aaharvidhividhan. Mindful eating nurtures the parasympathetic nervous system which further supports digestion by increasing salivary secretions, and stimulating gastric juices, digestive enzymes, and bile to facilitate nutrient assimilation and extraction.  This demonstrates the significance of mental health in maintenance of healthy status of Jatharagni.

For better mental strength, it is highly essential to enhance the Satva Guna. Satvavajaya Chikitsa is also considered one of the three pillars of treatment.  To protect the mind from unhealthy subjects, it is again essential to have a predominance of Satva.

To assess the level of Satva in an individual, Acharya Punarvasu has mentioned Satva examination under Dashavidha Pariksha . He has classified the level of Satva into three categories, namely Pravara, Madhyama, and Avara Satva. Further, he has also mentioned the qualities of Purush having the extent of Satva  Guna (Satvasara Purush). By assessing Satva, it is possible to enhance Satva Guna through Adravyabhuta Chikitsa (non-pharmacological interventions), Sadvritta (code of conduct), Yoga practices, meditation, Pranayama, and other therapies as part of the treatment. Avara Satva people are prone to psychological disorders; by these interventions we can prevent future psychosomatic disorders. Incorporating Satvasara assessment into treatment approaches can provide alternative or complimentary methods for managing mental health conditions.

REVIEW OF LITERATURE

The qualitative scale to assess the level of Satva as Pravar –Madhyam-Avar has been prescribed by Acharya Charak. The current published literature was searched to know the availability of tools for assessing Satva Sara. Aswathy et al  have developed a tool for the assessment of Satvasara based on the attributes given in Charak Samhita and divided them into the Attitude, Intellectual, and Activity domains.  Kiran et al have studied the use of assessment of Satvasarata (essence of psyche) in prognosis of female patient of breast cancer receiving chemotherapy. They used a Satvasara questionnaire developed by MUHS. Gaikwad et al. have observed the relationship between Satvasara and emotional maturity. Resmy et al  studied the correlation between Satvasara and stress among students at Ayurveda College. Stress is assessed by the Perceived Stress Scale 10. There is another tool by Ayusoft software  (C-DAC-Centre for Development of Advance Computing) for assessment of all types of Sara. This tool has sara and asara features for each Sara.

LACUNA IN THE EXISTING KNOWLEDGE

The tool for the assessment of Satvasara prescribed by Acharya Charak is qualitative and is in abstract form.

Though few researchers have worked in the past towards development and validation of Satvasara tool, lacunas were observed in the previous work. Aswathy et al. have developed a Satvasara assessment tool in which domain specific questions are not able to be identified. Questions are ambiguous and lack clarity. The questionnaire is lengthy, and the scoring pattern is also not clear. Kiran et al. used a Satvasara questionnaire which is not validated. The questions are not specific and need furthermore questions to catch the predictors. Dichotomous questions are only used to capture responses, which makes it difficult to assess the related attributes of an individual. Gaikwad et al. used a tool which is not available in the public domain. No data on structure, validation or reliability is available for this tool. Resmy et al. have studied the relationship between Stress and Satvasara. The tool used to assess Satvasara is not linked with published research. The tool prepared by Ayusoft C-DAC is very lengthy, assessment of only one sara is not possible, all dimensions essential to assess Satvasara of an individual is not included and the tool is not available in the public domain for free use.

NEED OF THE STUDY

There is no proper validated scale available in the public domain to assess the Satvasara. So, there is a need to develop and validate a quantitative scale in the form of questionnaire to assess the level of Satva in an individual. Status of mental well-being depends on the level of Satva. Individuals need an enhanced level of Satva to attain complete mental well-being. Assessment of Satvasara will offer a new approach in management of psychological disorders. Hence, there is a need to develop and validate a questionnaire for the assessment of Satva for the prediction of psychosomatic disorders. In the present study, Satvasara questionnaire will be developed and validated.

RESEARCH QUESTION

How to assess/measure Satvasara through a tool.

 

AIM OF THE STUDY

To develop and validate a questionnaire to assess Satvasara

 

RESEARCH OBJECTIVES

1.         To develop a questionnaire on Satvasara.

2.         To validate Satvasara questionnaire.

MATERIALS AND METHODS

Development and validation of preliminary questionnaire to assess Satvasara

Based on the classical texts and available literature, the predictors will be compiled.

The questions will be frame under various domains for different predictors.

For face validity, the questionnaire will be reviewed by the experts to look for any corrections.

Changes will be made according to expert’s suggestions, and the questionnaire will be revised.

For content validity, the questionnaire will be sent to 10-15 experts for their expert remarks.

The data will be analyzed using appropriate statistical tools.

Pilot testing will be done on 30 subjects. The questionnaire will be revised if needed.

The data will be analyzed to calculate Cronbach’s alpha for overall questions and for each question.

Inter-rater reliability and Intra-rater reliability will be checked, and the questionnaire will be finalized.

Study- Descriptive

Place of study: Delhi

Duration: 12 Months

SAMPLE SIZE :300

With reference from the article (Tsang S, Royse F, Terkwi A Guidelines for developing, translating and validating a questionnaire in perioperative and pain medicine Official publication of Saudi Anesthetic Association (SUPPL1) Page 12) and checking the feasibility of the research and research subjects we take the sample size to be 300.

INCLUSION AND EXCLUSION CRITERIA

INCLUSION CRITERIA

1.     Self-declared apparently healthy subjects aged 18-30 years.

2.     Individuals who have no history of any acute or chronic illness which may impact mental health of the individual.

3.     Individuals willing and able to participate in the study.

EXCLUSION CRITERIA

1.     Individuals having history of any psychological/psychiatric disorder.

2.     Individuals who are on any kind of medication.

3.     Individuals who underwent counseling by the psychologist.

PLAN OF STUDY

Questionnaire will be developed and validated for the assessment of Satvasra

The study participants will be enrolled after taking the informed consent

Satvasara will be assessed using the developed questionnaire through online google forms or by the physical form

The data will be compiled and analyzed. Findings will be submitted in the form of thesis.

OUTCOME OF STUDY

Development of standardized questionnaire for the assessment of Satvasara.

Validation of Satvasara questionnaire.

 
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