| CTRI Number |
CTRI/2022/11/047359 [Registered on: 16/11/2022] Trial Registered Prospectively |
| Last Modified On: |
15/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yogic Practices on health of Vata Prakrati Individuals. |
|
Scientific Title of Study
|
Effect Of Prakriti Specific Yogic Practices On Certain Health Parameters among healthy individuals of Vata Pradhana Prakriti |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghvendra Chaturvedi |
| Designation |
Research Scholar |
| Affiliation |
Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8090841361 |
| Fax |
|
| Email |
yogacharyaraghvendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangalagowri V Rao |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8178704037 |
| Fax |
|
| Email |
mangowri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangalagowri V Rao |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Medical Sciences, Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8178704037 |
| Fax |
|
| Email |
mangowri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal hospital, Banaras Hindu University, Varanasi, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Sir Sunder Lal Hospital, Institute of Medical Sciences, Banaras
Hindu University, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Raghvendra Chaturvedi |
Department of Swasthavritta and Yoga,
Dhanwantri Bhawan, Faculty of
Ayurveda,Institute of Medical Sciences, Banaras
Hindu University, Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Raghvendra Chaturvedi |
BHU campus |
main campus, Banaras Hindu university
Varanasi
UTTAR PRADESH |
8090841361
yogacharyaraghvendra@gmail.com |
| Raghvendra Chaturvedi |
OPD -16D of swasthavritta and yoga |
room no. 16D, ayurveda wing, sir sunderlal hospital,
IMS-BHU,
Varanasi
Varanasi
UTTAR PRADESH |
8090841361
yogacharyaraghvendra@gmail.com |
| Raghvendra chaturvedi |
Patanjali yoga hall |
Yoga hall,Department of Swasthavritta and yoga,
Faculty of ayurveda,
IMS-BHU
Varanasi
UTTAR PRADESH |
8090841361
yogacharyaraghvendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy person |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Yogic practices |
General yoga practices (60 min) including asana and pranayama for period of 03 months. |
| Intervention |
Prakriti specific Yogic Practice (Vata pradhana prakriti) |
yogic practices(Asana, pranayama) 60min per day for period of 03 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Vata Pradhana Prakriti persons after assessment, Person should be apparently healthy.
|
|
| ExclusionCriteria |
| Details |
Persons taking any regular medicines, major surgery in the last six months, any serious systematic illness, Pregnant females and lactating mothers, regular yoga Practitioner.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physical health(Fitness ,Physical ill-health),Mental Health(Mental Toughness,Mental ill-health),Social Health By swasthya assessment scale (SAS) |
In first week and after 03months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Body mass index (BMI)
2.Random Sugar level
3.Blood pressure
4.Hip and waist ratio
|
before and after 03months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 2 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Health is essential for multi-dimensional human development and excellence. Yoga is the most practical method for achieving personal and professional excellence with a positive side effect of higher mental transformation. Ayurveda emphasises individualised management based on the body constitution or ‘Prakriti’ to potentiate ‘Bala’ or strength. This study will be conducted to evaluate the effect of Prakriti Specific Yogic Practices on certain Health Parameters among healthy individuals of Vata Pradhana Prakriti. The study has total of 102 samples. After Prakriti’s assessment, samples will be randomly allocated into two groups. Before and after the intervention, the primary outcome will be recorded in the form of Self-recorded swasthya assessment scale (SAS) by Prajna Paramita Panda, Dr Shivakumar S. Harti, and Dr Mangalagowri V. Rao, and the Secondary outcome will be assessed in the form of BMI criteria, blood pressure, hip-waist ratio and random blood sugar. |