| CTRI Number |
CTRI/2010/091/001171 [Registered on: 14/09/2010] |
| Last Modified On: |
02/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
study to evaluate effect of naturopathy and yoga in modification of coronary risk factors |
|
Scientific Title of Study
|
Randomized wait listed control clinical study to determine the effect of naturopathy and yoga interventions in modification of coronary risk factors. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S.N.Murthy |
| Designation |
|
| Affiliation |
|
| Address |
INYS-Medical Research Society.Jindal Nagar
Tunkur Road
Bangalore
KARNATAKA
560073
India |
| Phone |
080-23717777 |
| Fax |
080-23717785 |
| Email |
cmo@jindalnaturecure.org |
|
Details of Contact Person
Scientific Query
|
| Name |
S.N.Murthy |
| Designation |
|
| Affiliation |
CMO |
| Address |
INYS-Medical Research Society.Jindal Nagar
Tunkur Road
Bangalore
KARNATAKA
560073
India |
| Phone |
080-23717777 |
| Fax |
080-23717785 |
| Email |
cmo@jindalnaturecure.org |
|
Details of Contact Person
Public Query
|
| Name |
S.N.Murthy |
| Designation |
|
| Affiliation |
|
| Address |
INYS-Medical Research Society.Jindal Nagar
Tunkur Road
Bangalore
KARNATAKA
560073
India |
| Phone |
080-23717777 |
| Fax |
080-23717785 |
| Email |
cmo@jindalnaturecure.org |
|
|
Source of Monetary or Material Support
|
| INYS-medical research society.Bangalore.Karnataka. |
|
Primary Sponsor
Modification(s)
|
| Name |
INYSmedical research societyBangaloreKarnataka |
| Address |
Jindal Nagar Tumkur Road Bangalore |
| Type of Sponsor |
Research institution |
|
|
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.Avinash Kadam |
INYS-MRS.Jindal Nature Cure Institutue. |
,Jindal Nagar ,Tumkur Road-560073
Bangalore
KARNATAKA |
080-23717777
080-23717785
dravinashkadam@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INYS-MRS,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
risk factors for coronory heart disease like diabetes/ obesity/metabolic syndrome/dyslipidemia/ hypertension or a combination of these ., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
naturopathy and yoga treatment |
21 days |
| Comparator Agent |
wait list control.education about life style modification |
21 days .followed by standard yoga and naturopathy treatement |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with BP,Obesity, type II DM, Prediabetes and dyslipidemia of both sexes (either one or a combination)
Age 18 years to 65 years.
|
|
| ExclusionCriteria |
| Details |
H/O CAD, Angina, TMT positive for inducible ischemia.
Uncontrolled hypertension SBP>200mmhg, DBP>100
Those who are on parental insulin, statins
Other therapies such as homeopathy / ayurveda etc
Pregnancy / Lactation,
Those with Hypothyroidism, Cushing?s syndrome, pheochromocytoma.
Intake of steroids / HRT
Ambulatory <50% of time
Those who are practicing yoga for last six months
Major psychiatric illness
Those with COPD, Congenital heart defects, Aortic aneurysm, DVT.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| . Resting blood pressure, Mean Arterial Pressure 2. FBG/ PPBG with 75gm glucose (2hr) 3. BMI, Skin fold thickness and anthropometry, Body fat percentage. 4. Lipid profile: VLDL, LDL, HDL, T Cholesterol (Serum Electrophoresis / direct enzymatic method, Triglycerides). 5. framingham cardiac risk score |
Baseline, 10days and 21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HADS Questionnaire, SCL 90 Somatization component , General Health Perceptions questionnaire , |
Baseline, 10days and 21days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/10/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomized wait listed controlled study.in this study the subjects will be randomly allotted to study group or wait listed group.subjects in study group will receive standard naturopathy and yoga treatment whereas subjects in wait listed group will receive advice and education on life style modification.after wait listed period of 21 days they will receive the standard naturopathy and yoga treatment as that of study group, |