A Randomized, Double-Blind, Parallel Group Clinical Study to evaluate Efficacy and Safety of a Novel herbal composition Flabonoid in subject with metabolic syndrome

Generix Lifesciences Pvt Ltd1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2015年11月17日最近更新: 2021年5月11日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 50
试验地点: 1
主要终点: Blood Pressure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study under trial is to investigate the efficacy of a novel herbal composition flabonoid which believed to be providing a solution for a condition known as metabolic syndrome. Flabonoid is a plant extract containing natural thrapeutic component known as Glabridin, a major polyphenolic flavonoid of G. glabra. The active igredient present in flabonoid is Kaneka glavonoid, which has different effect on humaan body like anti- oxidative, anti- H. pylori , anti- nephritic, radical scavenging activity, anti diabetic, anti-hypertensive, anti- hyperlipidemia anti-artherosclerotic and anti-obese effect. All these effects are essential to control the disorder called metabolic syndrome. So the aim of this study is to evaluate the clinical effectiveness of the flabonoid versus placebo in patient with metabolic syndrome having age relaxation between 18 to 75 , with satisfying the NCEP ATP III criteria. Enrolled subject will receive either flabonoid or placebo for 84 days.At last the effectiveness of flabonoid will be compared with placebo.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•1 Male or female subjects between 18 to 75 years of age 2 Ability to understand the risks/benefits of the protocol 3 Female subjects of childbearing potential must be using a medically acceptable form of birth control Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 4 Confirmed diagnosis of metabolic syndrome as per ATP-III guidelines This includes the presence of at least 3 or more of the following 5 factors (As per modified NCEP ATP III guidelines-specific for South Asia) Including Abdominal waist circumference > 90(males) >80 cm (females) And Increased blood pressure (>130/85 Hg) Serum triglycerides â‰¥ 150 mg/dL Serum HDL cholesterol < 40 mg/dL (males) < 50 mg/dL (females) Elevated fasting blood glucose â‰¥ 100 mg/dL 5 Subjects agree to maintain the activity dairy 6 If Former smoker (previously smoked â‰¥10 cigarettes/day for at least 1 year, cessation for at least 6 months 7 Willing to give written informed consent and willing to comply with trial protocol.

排除标准

•1 Pregnant or breast feeding women 2 Uncontrolled hypertension and Diabetes 3 Other cardiovascular disease or previous cardiovascular event These include a history of angina pectoris b history of heart failure c Presence of a cardiac pacemaker d History of myocardial infraction e Previous revascularization procedure 4 History of cerebrovascular disease including stroke and ischemic attack 5 Subjects having abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal elevated Creatinine males > 125 Î¼mol/L females > 110 Î¼mol/L renal insufficiency thyroid or other endocrine disease 6 Currently being treated for cancer (i e chemotherapy radiation therapy) 7 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 8 Any other condition that in the opinion of the investigator would adversely affect the subjects ability to complete the study or its measures 9 Patient on any medication which is known to modify signs and other parameters of metabolic syndrome 10 Hypersensitivity to any of the ingredient used in the study supplements 11 Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day for men or 1 drink/day for women) 12 Subjects participated in any investigational study medication within thirty (30) days prior to screening.