| CTRI Number |
CTRI/2024/09/073606 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Effectiveness of Trataka and Bhramari Pranayama in Enhancing the Cognitive Skills of the Working Population. |
|
Scientific Title of Study
|
A Randomized Clinical Comparative Study to Evaluate the Efficacy of Trataka and Bhramari Pranayama in Enhancing Cognitive Skills of the Working Population. |
| 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 Shital S Mahadik |
| Designation |
Associate Professor |
| Affiliation |
Institute For Ayurved Studies And Research Faculty Of Ayurved |
| Address |
OPD Number 2, Shri Krishna Government Ayurvedic Hospital, Kurukshetra, Haryana.
Kurukshetra
HARYANA
136118
India |
| Phone |
09518681904 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Riya Bhatia |
| Designation |
Associate Professor |
| Affiliation |
Institute For Ayurved Studies And Research Faculty Of Ayurved |
| Address |
Postgraduate Department of Swasthavritta and Yoga, Institute for Ayurvedic Studies and Research, Shri Krishna AYUSH University, Sector 8, Umri Road, Kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
8168618595 |
| Fax |
|
| Email |
bhatia151295@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital S Mahadik |
| Designation |
Associate Professor |
| Affiliation |
Institute For Ayurved Studies And Research Faculty Of Ayurved |
| Address |
OPD Number 2, Shri Krishna Government Ayurvedic Hospital, Kurukshetra, Haryana.
Kurukshetra
HARYANA
136118
India |
| Phone |
09518681904 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, Kurukshetra, Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research Faculty Of Ayurved |
| Address |
Institute for Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, Kurukshetra, Haryana 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 Shital S Mahadik |
Shri Krishna Govt. Ayurvedic Hospital Kurukshetra , haryana |
OPD NO 2, Department of Swasthvritta and Yoga
Kurukshetra
HARYANA |
9518681904
shitalsingla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Shri krishna ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
workload stess |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:trataka kriya
bhramari pranayama, Pathya/Apathya:yes, Pathya:healthy vegetarian diet , Apathya:alcohol, smoking, controlling natural ergs, nonvegetarian diet |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Working population who knows how to read and write
2.No history of pranayama practice
3.Patient having PSS score between 14-40
4. Patient having ACE III above 83
|
|
| ExclusionCriteria |
| Details |
1.Patients having age below 30 years and more than 60yrs.
2.Patients having any kind of medical emergency .
3.Patient suffering from glaucoma , conjunctivitis, keratitis or any other kind of infections eye disease, myopia, hypermetropia
4.Patient having PSS score below 13
5.Patient having any kind of psychiatry problems. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in perceive stressed scale from mild to moderate
Mild – PSS decreased by 1
Moderate – PSS decreased by 2
Increase in ADDENBROOKEE’S COGNITIVE EXAMINATION III from mild to moderate
Mild – ACE III increased by 1
Moderate – ACE III increased by 2 |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The lifestyle of patient improved with Enhancement in cognitive skill
Improvement in memory
Improvement Sleep quality |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/09/2024 |
| 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="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
|
24% Indians struggling with Stress GOQii India Fit Report 2022-23 . Since last year, job losses , pay cuts and mental health issues have become more common in working population .The current work environment has become stressful with long working hours , lack of job security ,low wages and growing competition . People are unable to deal with or find ways to tackle the situation . This has led to a lot of anxiety and stress. Sustained exposure to stress induces dysregulation of stress coping mechanism and cognitive functions. According to WHO Long term stress represents a potential risk factors for cognitive decline as it may have adverse effect on brain heath .YOGA is being an integrated mind body practice .It has been working to promote health and well being across various condition .Pranayama being a part of asthangyog is performed for controlling the flow of vital energy that governs are all the physiological process in the body.Many previous studies shows that yoga and pranayama play great role in autonomic nervous system imbalance , hormonal imbalance and stress related disorders .Therefore the study is to evaluate the efficacy of Trataka and Bhramari prayanama in enhancing cognitive skills of working population. Total 60 patients will be randomly selected for the study, with ages ranging from 30 years to 60 years, irrespective of gender, religion, occupation, socio – economic status etc. DURATION 45 day INCLUSION CRITERIA:1.Patients between the 30 to 60 years of age .2. Working population who knows how to read and write.3.No history of pranayama practice .4.Patient having PSS ( score between 14 to 40.)5.Patient having ACE III above 83 EXCLUSION CRITERIA:1.Patients having age below 30 years and more than 60yrs. 2.Patients having any kind of medical emergency . 3.Patient suffering from glaucoma , conjunctivitis, keratitis or any other kind of infections eye disease, myopia, hypermetropia 4. Patient having PSS score below 13 ,5.Patient having any kind of psychiatry problems. ■Primary outcome : ■Decrease in perceive stressed scale ■Increase in ADDENBROOKEE’S COGNITIVE EXAMINATION III ■Secondary outcome: ■Increase in memory ,sleep quality ■Enhance cognitive skills ■Decrease in stress level
|