| CTRI Number |
CTRI/2017/03/008208 [Registered on: 27/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of yoga on cardiovascular risks in sons, daughters, sisters and brothers of hypertensives and type 2 diabetics |
|
Scientific Title of Study
|
Effect of yoga on cardiovascular risks in first degree relatives
of hypertensives and type 2 diabetics
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopal Krushna Pal |
| Designation |
Professor & Head |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
| Address |
Professor & Head,
Professor & Head
Department of Physiology, JIPMER
Program Director, Advance Center of Yoga,
JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
0413-2912114 |
| Fax |
0413-2272067 |
| Email |
drgkpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopal Krushna Pal |
| Designation |
Professor & Head |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
| Address |
Professor & Head,
Professor & Head
Department of Physiology, JIPMER
Program Director, Advance Center of Yoga,
JIPMER, Puducherry
PONDICHERRY
605006
India |
| Phone |
0413-2912114 |
| Fax |
0413-2272067 |
| Email |
drgkpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopal Krushna Pal |
| Designation |
Professor & Head |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
| Address |
Professor & Head,
Professor & Head
Department of Physiology, JIPMER
Program Director, Advance Center of Yoga,
JIPMER, Puducherry
PONDICHERRY
605006
India |
| Phone |
0413-2912114 |
| Fax |
0413-2272067 |
| Email |
drgkpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER), Dhanavantari Nagar, Puducherry, PIN-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Post graduate Medical Education and Research JIPMER |
| Address |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER)
Dhanvantari Nagar
Puducherry
605006 |
| 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 |
| Dr Gopal Krushna Pal |
Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) |
Dept. of Medicine, Physiology, Advance center for Yoga therapy Education and research (ACYTER) and Staff of JIPMER, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY |
0413-2912114
0413-2272067
drgkpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects who have the family history of Diabetes, Hypertension or Both |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator agent |
No comparator agent |
| Intervention |
Yoga will be given as intervention |
The Yoga sessions will be conducted three times in a week, and they will be advised to perform yoga rest four days at home for twelve weeks. In nutshell the following yoga procedures will be practiced.
Yoga module for CVD risks
Loosening Practices (2 min)
1. Shoulder joint rotation
2. Elbow extension and flexion
3. Elbow supination and pronation
4. Wrist joints extension and flexion
5. Knee joints extension and flexion
Asana (3 min)
1. Tadasana
2. Makarasana
3. Bhujangasana
Pranayama (30 min)
1. Sukha pranayama
2. Nadi shodhana pranayama
3. Chandranadi pranayama
4. Ujjai pranayama
5. Bhramari Pranayama
6. Sitkari pranayama
Meditation (4 min)
Pranava dhyana (A-U-M)
Relaxation (6 min)
1. Shavasana
2. Yoga-nidra
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Adult males and females of age 18 -40 years, who are first degree relatives (sons, daughters, sisters and brothers) of hypertensives or diabetics or both, who have been under therapy for at least one year |
|
| ExclusionCriteria |
| Details |
Subjects, who are
Diabetics,
Hypertensives,
Alcoholics,
Sportspersons,
receiving hormonal therapy,
severe Kidney diseases and
other endocrine disorders,
will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Twelve weeks of yoga therapy is expected to reduce the blood pressure in first degree relatives of hypertensives and diabetics |
Twelve weeks of yoga therapy is expected to reduce the blood pressure in first degree relatives of hypertensives and diabetics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improve cardiovascular autonomic functions,
reduce fasting blood glucose,
insulin resistance,
lipid risk factors,
inflammatory markers (hsCRP, IL-6, Homocysteine,
Adiponectin, TNF-alpha),
endothelial marker (vWF),
total oxidant level, and
increase anti-oxidant level (Total anti-oxidant status)
|
Parameters will be recorded two time during study process, immediately after recruiting and after twelve weeks of yoga therapy |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
01/06/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
participants are currently being recruited and enrolled
The subjects (healthy first degree relations of hypertensives and diabetics) in 18 – 40 years of age are being recruited from medicine OPD and from the staff of JIPMER
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an interventional, comparative study assessing the effect of yoga practice on cardiovascular risks in 180 participants who are healthy first degree relatives (sons, daughters, sisters and brothers) of hypertensives and type 2 diabetics compared to 60 control subjects (healthy subjects who are NOT first degree relatives of hypertensives and type 2 diabetics). The study will be conducted in one year in JIPMER Hospital, Puducherry, India. The primary outcome i.e., blood pressure and the secondary outcomes like cardiovascular autonomic functions, fasting blood glucose, insulin resistance, lipid risk factors, Inflammatory markers (hsCRP, IL-6, Homocysteine, Adiponectin, TNF-alpha), endothelial marker (vWF), total oxidant level, and anti-oxidant level (total anti-oxidant status) will be recorded before and after 12weeks of yoga therapy. |