| 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
|
|
|
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 dharan. Manasik 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 Vegasâ€, 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. |