Effect of Nigella Sativa on Lipid Profiles in Elderly: a Randomized Double-blinded Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL
研究概览
简要总结
The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.
详细描述
Cardiovascular diseases are still common health problems worldwide. They are major causes of morbidity and mortality in many countries. Dyslipidemia is the main risk factor of cardiovascular events. Despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. However, evidence of the effectiveness of many herbs or other traditional drugs is lacking. Nigella sativa or black seeds are traditional herbs used for years in Middle East and India. They are believed to cure many diseases, including dyslipidemia. Therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 60 years or more
- •having dyslipidemia (total cholesterol >200 mg/dL or LDL >100 mg/dL or triglyceride > 150 mg/dL or HDL < 40 mg/dL (male) or HDL < 50 mg/dL (female)
排除标准
- •ALT or AST are two times of upper normal limit
- •creatinine clearance test is below 30
研究组 & 干预措施
Nigella sativa
Nigella sativa extracts, 300 mg twice daily
干预措施: Nigella sative (Drug)
Placebo
干预措施: black sticky rice (Dietary Supplement)
结局指标
主要结局
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL
时间窗: 56 days
次要结局
未报告次要终点
研究者
Jimmy Tandradynata
Dr.
Indonesia University