| CTRI Number |
CTRI/2013/05/003690 [Registered on: 28/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga on Hypertension |
|
Scientific Title of Study
|
Effect of Yoga on Examination Stress and Hypertension: A Biochemical and Molecular Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SSwapna |
| Designation |
Research Scholar |
| Affiliation |
SRM Medical College Hospital & Research centre |
| Address |
Department of Medical Research
SRM Medical College Hospital and Research Centre
Kattankulathur-603203
Tamilnadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
swapnamanian@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGaneshkumarP |
| Designation |
Assistant professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Community Medicine
SRM Medical College Hospital and Research Centre
Kattankulathur-603203
Tamilnadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
ganeshkumardr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SSwapna |
| Designation |
Research Scholar |
| Affiliation |
|
| Address |
Department of Medical Research
SRM Medical College Hospital and Research Centre
Kattankulathur-603203
Tamilnadu, India.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
swapnamanian@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM University |
| Address |
SRM Medical College Hospital and Research Centre,
Kattankulathur-603203
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SwapnaS |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre,
Kattankulathur-603203,
Tamilnadu, India.
Kancheepuram
TAMIL NADU |
9840653278
swapnamanian@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTER SRM NAGAR, POTHERI, KATTANKULATHUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug alone |
Anti Hypertensive drug for 6 months |
| Comparator Agent |
Excercise |
Aerobic Excercise for 6 months |
| Intervention |
Yoga |
Practice of Yoga which included simple asanas, Breathing, Exercise, sudarshan Kriya and Pranayam, Meditation for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
28.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Recently diagonsed essential hypertensives
non smokers
non alcoholics |
|
| ExclusionCriteria |
| Details |
hypertensives with renal failure
congestive cardiac failure
retinopathy
other secondary complications of hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BLOOD PRESSURE AND LIPID PROFILE |
Before and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oxidative stress markers, inflammatory markers, protein and gene expression of iNOS |
Before and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="127"
Sample Size from India="127"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This was a randomized control study to investigate the effect of yoga on recently diagnosed essential hypertensive patients with reference to oxidative stress markers and gene expression in comparison with exercise. After screening for selection criteria and consent to participate in the study, 127 essential hypertensive patients were included. Out of the 127 patients, randomly 42 subjects were intervened by yoga by a trained yoga teacher, 42 subjects were intervened by aerobic exercise by a trained physiotherapist and 43 were followed by drug therapy alone.There were 9 drop outs in the study(2 in the drug therapy, 4 in yoga group and 3 in aerobic exercise group). The outcome measurements were done before and after 6 months of intervention. |