Effect of Naturopathy and yoga based lifestyle interventions on inflammation and utilization of insulin in patients with high risk of cardiovascular diseases

Phase 4

Conditions: Health Condition 1: null- Presence of one or more of following Cardiovascular risk factors HypertensionDiabetesDyslipidemiaObesity

Lead Sponsor: Institute of Naturopathy and Yogic Sciences Medical Research Society INYSMRS

Recruitment & Eligibility

Inclusion Criteria

Subjects of both sexes aged 18 years to 65 years with either of the following criteria

•Subjects with high blood pressure (DBP > 90 mm/hg SBP >140mm/hg or on antihypertensive medications)

•Obesity(BMI >25)

• Pre-diabetes (FBS-110 to 125 mg/Dl/ PPBS 140 to 199 mg/Dl)

•Type II DM (FBS >126 mg/dl/PPBS > 200 mg/dl)

•and dyslipidemia (As per NCEP ATP III criteria)

Exclusion Criteria

•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 for treating above mentioned conditions.

•Pregnancy / Lactation,

•Those with Hypothyroidism, Cushingâ??s syndrome, pheochromocytoma.

•Intake of steroids / HRT/Non steroidal anti-inflammatory drugs (other than low dose asprin < 150mg/day)

•Those who are practicing yoga for last six months

•Major psychiatric illness

•Those with COPD, Congenital heart defects, Aortic aneurysm, DVT.

•Those with Active infection , Systemic Inflammatory Disease ,Autoimmune disorders , Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA)

•Any other condition which in the opinion of the investigator will place the subject for increased risk or will influence the outcome of the study.

Primary Outcome Measures

Name	Time	Method
1.High sensitivity C reactive protein <br/ ><br>2.Serum fasting insulin <br/ ><br>3.FBG/ PPBG with 75gm glucose (2hr) <br/ ><br>4.HOMA â??IR <br/ ><br>Timepoint: Baseline, 10days and 21days.

Secondary Outcome Measures

Name	Time	Method
Resting blood pressure, Mean Arterial Pressure <br/ ><br>Autonomic function test: Deep breathing test, hand grip test, Valsalva maneuver, Heart rate variability. <br/ ><br>BMI, Body fat percentage, waist and hip circumference. <br/ ><br>Lipid profile: VLDL, LDL, HDL, T Cholesterol (Serum Electrophoresis / direct enzymatic method, Triglycerides). <br/ ><br>Timepoint: Baseline, 10days and 21days.