Randomized wait listed control clinical study to determine the effect of naturopathy and yoga interventions in modification of coronary risk factors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- . 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
研究概览
简要总结
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with BP,Obesity, type II DM, Prediabetes and dyslipidemia of both sexes (either one or a combination) Age 18 years to 65 years.
排除标准
- •H/O CAD, Angina, TMT positive for inducible ischemia.Uncontrolled hypertension SBP>200mmhg, DBP>100Those who are on parental insulin, statinsOther therapies such as homeopathy / ayurveda etcPregnancy / Lactation,Those with Hypothyroidism, Cushing?s syndrome, pheochromocytoma.Intake of steroids / HRTAmbulatory <50% of time Those who are practicing yoga for last six monthsMajor psychiatric illnessThose with COPD, Congenital heart defects, Aortic aneurysm, DVT.
结局指标
主要结局
. 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
时间窗: Baseline, 10days and 21days
次要结局
- HADS Questionnaire, SCL 90 Somatization component , General Health Perceptions questionnaire ,(Baseline, 10days and 21days)