| CTRI Number |
CTRI/2024/07/071688 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study aims at creating a questionnaire to assess how much a person follows ethical principles (which are called as yamas and niyamas) in his life according to yoga philosophy |
|
Scientific Title of Study
|
Development and validation of Yogic assessments of mental afflictions YAMS scale |
| 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 Hemant Bhargav |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 560029, India
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 560029, India
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Vashishth |
| Designation |
PG Student |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore 560029, India
Bangalore
KARNATAKA
560029
India |
| Phone |
7021215711 |
| Fax |
|
| Email |
sv290500@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Bhargav |
National Institute of Mental Health and Neurosciences(NIMHANS) |
Ground Floor, Yoga Center, Department of Integrative Medicine
Bangalore
KARNATAKA |
8762109348
drbhargav.nimhans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and Integrative Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers will be assessed by GHQ-12 scores (cut off less than 3) |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, (2) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
Language knowledge (ability to read and write) in English
Above age of 25 years
Healthy subjects: (as screened through the general health questionnaire, GHQ-12 cut off below 3).
Patients: Those diagnosed with depression and anxiety as per DSM-5 criteria
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
Participants with cognitive disabilities or an inability to understand questionnaire (as assessed by HMSE(Hindi mental status exam).
Patients with severe mental illnesses who find it difficult to comprehend or fill the questionnaire.
Those with psychotic disorders
Patients with suicidal risk (as assessed through clinical interviews and HAM-D questionnaire)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and validate yogic assessment of mental afflictions or kleshas (yama) scale among healthy subjects and in patients with anxiety and depression disorders respectively. |
NA |
|
|
Secondary Outcome
|
|
|
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)
|
02/09/2024 |
| 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="3"
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 research study being conducted at the
National Institute of Mental Health and Neurosciences, Bengaluru, to develop and validate a
yogic assessment of mental afflictions (YAMA) scale. We are trying to
understand mental health difficulties from yoga philosophy
perspectives. There is an ancient yogic text called Patanjali Yoga Sutra which
describes factors that can enhance mental health and factors that can disturb
the mental health. We would like to develop a questionnaire based on these
principles. We have named this tool as YAMA scale which stands for yogic
assessments of mental afflictions. |