CTRI/2015/11/006366已完成4 期
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 Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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)
- •Abdominal waist circumference > 90(males) >80 cm (females) And
- •Increased blood pressure ( >130/85 Hg)
- •Serum triglycerides ââ?°Â¥ 150 mg/dL
- •Serum HDL cholesterol < 40 mg/dL (males) < 50 mg/dL (females)
- •Elevated fasting blood glucose ââ?°Â¥ 100 mg/dL
- •5 Subjects agree to maintain the activity dairy
- •6 If Former smoker (previously smoked ââ?°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 Ã?¼mol/L females > 110 Ã?¼mol/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
研究者
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