CTRI/2017/06/008903进行中（未招募）不适用
A randomized, double blind, controlled clinical trial to assess the Efficacy and safety of liposomal Curcumin compared with Curcumin (non-liposomal) on inflammation in subjects with metabolic syndrome
CureSupport1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年6月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.
研究概览
简要总结
The purpose of the study is to investigate the liposomal curcumin efficacy and safety on inflammatory markers, lipid profile, blood glucose etc. in patients with metabolic syndrome. Liposomal curcumin product has been encapsulated inliposomes. Liposomes are small lipid globules that are created naturally whenwater is mixed with lecithin, an ingredient of soy beans. Liposomes are readilyabsorbed by the body. When Liposomal Cureit curcumin is mixed with lecithin itis encapsulated by the liposomes. The result is an improved absorption ofcurcumin in the blood.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •18 years of age and above
- •Metabolic abnormalities with or without alcohol consumption and/or smoking
- •Diagnosis of MetS ie.
- •the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III): 3.1 Waist circumference 90 cm in men and 80 cm in women 3.2 Hypertriglyceridemia ≥ 150 mg/dl 3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females 3.4 Blood pressure ≥ 130/85 mm Hg 3.5 Fasting plasma glucose ≥ 110 mg/dl 4.0 Patients willing to provide written informed consent.
排除标准
- •Pregnancy or breastfeeding,
- •lack of compliance with the study medication (defined as not using the medication for >1 week),
- •Participation in a concomitant trial,
- •Hypersensitivity to the study medication,
- •Presence of malignancies
- •Intake of drugs or dietary supplements
- •Previous illnesses such as heart attack, cancer or dementia
- •Addiction illness.
结局指标
主要结局
Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.
时间窗: Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.
次要结局
- Plasma tumor necrosis factor alpha at baseline and 6 weeks(Plasma interleukine 6 at Baseline and 6 weeks)
研究者
研究点 (1)
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