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CTRI Number  CTRI/2024/07/071225 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation of Dharaniya Vega with Generalized Anxiety Disorder(GAD)a holistic Approach 
Scientific Title of Study   Correlation of overt expression of Dharaniya Vega with Generalized Anxiety Disorder a holistic perspective 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanika Gujar 
Designation  UG Scholar BAMS 
Affiliation  Bharati Vidyapeeth Demeed to be University College of Ayurved Dept of Swasthavritta & Yoga 
Address  Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Pune Satara Road Pune 411043. (India)
Pune Satara Road
Pune
MAHARASHTRA
411043
India 
Phone  919370120478  
Fax    
Email  sanikagujar2010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKirti Bhati 
Designation  Professor and Hod 
Affiliation  Bharati Vidyapeeth (Demeed to be University) College of Ayurved dept of Swasthavritta;& Yoga 
Address  Deptment of Swasthavritta and Yoga Bharati Vidyapeeth Deemed To Be University College of Ayurved Pune Pune Satara Road
Bharati Vidyapeeth Deemed To Be University College of Ayurved Pune Pune Satara Road
Pune
MAHARASHTRA
411043
India 
Phone  09423010166  
Fax    
Email  kirti.bhati@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  DrKirti Bhati 
Designation  Professor and Hod 
Affiliation  Bharati Vidyapeeth (Demeed to be University) College of Ayurved dept of Swasthavritta;& Yoga 
Address  Deptment of Swasthavritta and Yoga Bharati Vidyapeeth Deemed To Be University College of Ayurved Pune Pune Satara Road
Bharati Vidyapeeth Deemed To Be University College of Ayurved Pune Pune Satara Road
Pune
MAHARASHTRA
411043
India 
Phone  09423010166  
Fax    
Email  kirti.bhati@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Studentship Program for Ayurveda Research Ken (SPARK) CCRAS 61-65, opposite D Block, Institutional Area, Janakpuri, New Delhi - 110058 
 
Primary Sponsor  
Name  Studentship Program for Ayurveda Research Ken SPARK CCRAS 
Address  CCRAS 61 65 Janakpuri New Delhi 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
self  Bharati Vidyapeeth Deemed to be University College of Ayurved Pune 411043 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirti Bhati  Bharati Vidyapeeth Deemed to be University College and Hospital Pune  Bharati vidyapeeth deemed to be university Ayurved Hospital OPD No 15 Swasthavritta and Yoga Swasthavritta opd nn 15 ground floor Katraj Dhankawadi Pune Pune MAHARASHTRA
Pune
MAHARASHTRA 
9370120478

sanikagujar2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BV(DU)COA Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Generalized Anxiety Disorder,Dharana of Dharaniya vegas 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  This will include a normal population without any disease specificity. The student population of mainly under graduates and post graduates will be focused. The working population will also be considered. 
 
ExclusionCriteria 
Details  Below the age of 18 years and above the age of 30 years.
This will include a normal population with any disease specificity. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Data generating correlation of each Dharaniya vega with the score of GAD-7 in regard to control and suppression of urges.  1 month and 15days 
 
Secondary Outcome  
Outcome  TimePoints 
Overview of the status of each vega in an individual as per the scale presented.Individual assessment of 9 Dharaniya Vega generating 900 observations with respect to the 4 groups of population as per GAD-7 scores.   1 month for survey and 15 days for analysis. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)  15/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
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  

Attempts must be made to solve the arising crisis of anxiety among the common population by providing an Ayurvedic perspective. GAD affects about 6.8 million people in India and is commonly seen in adolescence and adulthood. Individuals with anxiety may maintain normal social and physical health, yet anxiety lurks as a masked unwanted feeling hindering their lives. This masked anxiety may be related to the manasik vegas and their dharanManasik vegas are feelings people deal with every day and often give least importance to in terms of being measured, expressed, controlled or suppressed. Ayurveda is known for its simple approach to curing major diseases and hence, the daily arising feelings and their right management could be linked to understanding of the mental health deteriorating aspects of anxiety. Its principles have the potential to correlate anxiety with “Dharaniya Vegas”, mainly the dharan (suppression) of the 9 manasik vegas highlighted by Acharya Charak.

Manasa bhav (mental feelings) like greed, grief, anger, etc. are present in every person, and the imbalance of these may lead to problems affecting the mental and social well-being of an individual. A specific emotion can act as a trigger factor towards momentary anxiety. Also, any of these 9 emotions could be a cause of a lifetime of anxiety. Ayurveda might have answers to the factors leading to and affecting the severity of anxiety. A quantitative measure of the vegas with a scale of anxiety will act as an appreciation towards the understanding of a neoteric issue in terms of holistic sciences.

A detailed survey will be conducted among individuals of age group 18 to 30. These individuals will have to answer two questionnaires in particular. The first one will be a quantitative measure of GAD by the standardized GAD-7 scale which will be a self-diagnostic measure. The next will be a general quantitative questionnaire on Dharaniya vegas designed and verified by professionals to measure the control and suppression of the 9 Dharaniya vegas mentioned in Charak Samhita.

Outcome- Overview of the status of each vega in an individual as per the scale presented.Individual assessment of 9 Dharaniya Vega generating 900 observations with respect to the 4 groups of population as per GAD-7 score.

Implications and Future Scope: The comparative study will provide a quantitative understanding of how the manasik vegas are related to the Generalised Anxiety Disorder (specifically to the GAD-7 scale). The correlation may prove the theoretical principle of Dharaniya Vegas to be applicable in the diagnosis and cure of anxiety as well as other related mental health issues.  

 

 
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