Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary end point for the trial is serum low-density lipoprotein (LDL) cholesterol concentration measured at six weeks after intervention.
研究概览
简要总结
This is a pilot study.
The aim of the investigators' study is to evaluate the effectiveness of nigella sativa seed in the treatment of dyslipidemia.
Dyslipidemia is a common risk factor for cardiovascular disease, the leading cause for morbidity and mortality among patients.
Nigella sativa is an easily available and acceptable remedy to treat dyslipidemia and at a low cost.
It is expected that by scientifically determining the effectiveness of this intervention it will lead to its widespread use.
This will provide a low cost alternative to treat dyslipidemia.
详细描述
- Pakistan is a developing country with limited resources and a high prevalence of dyslipidemia.
- Nigella sativa is a small plant originating in the Middle East and is found abundantly, growing wild in Egypt, Asiatic Turkey and the Balkan States.
- The seed extracts from this plant are used by herbalists in the treatment of several medical disorders including dyslipidemia.
OBJECTIVE:
To determine the effectiveness of the nigella sativa seed in the control of dyslipidemia in adults. This is a pilot study.
METHODOLOGY
DESIGN
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (18 years or older) men and women
- •Serum cholesterol > 180 mgs/dl
- •Provide Informed Consent
排除标准
- •Diabetes mellitus
研究组 & 干预措施
Nigella sativa seed
干预措施: Nigella sativa seed (Drug)
结局指标
主要结局
The primary end point for the trial is serum low-density lipoprotein (LDL) cholesterol concentration measured at six weeks after intervention.
时间窗: six weeks
次要结局
- Serum total cholesterol concentrations measured at six weeks after intervention(six weeks)
- Serum concentrations of high-density lipoprotein (HDL) cholesterol measured at six weeks after intervention(six weeks)
- Serum triglyceride concentrations measured at six weeks after intervention(six weeks)
- Serum blood sugar concentrations measured at six weeks after intervention(six weeks)
- Blood pressure measured at six weeks after intervention(six weeks)
- Changes in serum creatinine after six weeks intervention(six weeks)