A Randomized, Double-Blind, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of an Ayurvedic formulation (Slim MetS) in patients with Metabolic Syndrome (MetS)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in waist circumference (WC)
研究概览
简要总结
The metabolic syndrome (MetS) is increasingly being recognizedas a major threat to good health- especially cardiovascular health and itsfrequency appears to be increasing in relation to the current epidemic ofobesity. The epidemic of cardiovascular disease emerging in the developingcountries during the past two decades has attracted the attention ofcardiologists, diabetologists, endocrinologists and epidemiologists. It is awell established fact that all of the ethnic groups in the world, South Asianshave the highest incidence of coronary artery disease (CAD). As we have emergedas a diabetes capital of the world, the incidence of coronary artery disease isexpected to rise several folds, increasingly affecting younger subsets of ourpopulation who are often in the prime of their lives. The economic and healthcare burden on our society is likely to be enormous. A major factor responsiblefor this dismal scenario is the occurrence of a peculiar set of metabolic andcardiovascular abnormalities that affects our society, known as Metabolicsyndrome (MetS). It is a multifaceted syndrome responsible for type 2 diabetesmellitus, obesity, hypertension, dyslipidaemia, hyperinsulinaemia andatherosclerotic cardiovascular diseases (ASCVD). Abdominal obesity and insulinresistance are the main underlying abnormalities in the metabolic syndrome.Patients of metabolic syndrome present with almost similar co-morbidities tothat ofSantarpanaotha Pramehamentioned in Ayurvedictreaties. Modern drug therapy of metabolic syndrome may be limited by adversereactions, requiring alternative therapies. Herbal drugs are supposed to havebenefits with fewer side effects, so there is a need to evaluate these herbaldrugs scientifically. Therefore, it was decided to evaluate the glycaemic improving,weight reducing, insulin improving and hypolipidaemic effects of an Ayurvedicherbal formulation (Slim MetS)in patients with metabolicsyndrome*.*
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm (F), and two or more of these criteria:
- •fasting blood glucose >100 mg;
- •systolic blood pressure >135 or diastolic blood pressure >85 mmHg
- •triglyceridemia >150 mg/dl;
- •HDL cholesterolemia < 40 mg/dl (M), < 50 mg/dl(F).
- •Patient willing to participate in the study for 12 weeks.
排除标准
- •Patients with diabetes mellitus (FBS >126mg/dl);
- •Patients with blood pressure more than 160/100 mmHg.
- •Triglyceridemia > 500 mg/dl;
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc).
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia.
- •Symptomatic patients with clinical evidence of heart failure, hepatic failure and renal failure (serum creatinine >2 mg/dl).
- •Alcoholics and/or drug abusers.
- •Pregnant and lactating mothers
- •Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
Change in waist circumference (WC)
时间窗: 3 months
Change in Body Mass Index (BMI)
时间窗: 3 months
Change in Insulin Resistance using Homeostatic model assessment (HOMA-IR) index
时间窗: 3 months
Change in Insulin Resistance using quantitative insulin sensitivity check index (QUICKI)
时间窗: 3 months
次要结局
- Change in lipid profile(Change in systolic and diastolic blood pressure)