The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Serum total cholesterol level
研究概览
简要总结
Coronary heart disease and stroke are two main causes of human deaths and is directly related to increased levels of plasma lipids.High total cholesterol and low high density lipoprotein cholesterol concentrations are often associated with endothelium dysfunction and inflammation, which can be followed by atherosclerosis.
Rhus coriaria L. (Rhus) with the public name of "Somagh" is a plant species in the anacardiaceae family that is used as a food supplement, spice in Middle East region (Iran, Turkey and Arabic countries).
In a double blind randomized placebo-controlled clinical trial, the investigators want to evaluate the effects of Somagh (Rhus coriaria L.) on serum lipid levels of patients with hyperlipidemia.
详细描述
Rhus (Somagh) is found in temperate and tropical regions worldwide, often growing in areas of marginal agricultural capacity. Rhus is used as an herbal remedy in traditional medicine because of its assumed analgesic, antidiarrhetic, antiseptic, anorexic and antihypergylcemic properties. The fruits of Rhus contain flavonols, phenolic acids, hydrolysable tannins, anthocyans and organic acids such as malice, citric and tartaric acids. Some studies have shown that polyphenols could have beneficial effects on cardiovascular disease and cancer and could be regarded as bioactive compounds with a high potential health-promoting capacity. Phenolic compounds inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl radical, and enhance the activities of detoxifying enzymes.Moreover, the hypocholesterolemic action of dietary polyphenols has been reported. The hypocholesterolemic effect of Rhus fruit powder and its components have been reported previously in rabbits and mice.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-65 years
- •Serum triglyceride >150mg/dl AND/OR total cholesterol >= 240mg/dl
排除标准
- •Serum triglyceride > 500 mg/dl
- •Serum LDL-cholesterol at level which need drug treatment according to the patient risk categories (NCEP-ATP III)
- •Diabetes mellitus
- •Hypo. or hyperthyroidism
- •Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure
- •Use of drugs: OCPs, lipid lowering agents, thiazides
- •Pregnancy
- •Alcoholism
- •History of allergic reaction to Somagh
研究组 & 干预措施
Placebo
Placebo capsule: 1 capsule twice daily for 6 weeks
干预措施: Placebo (Drug)
Rhus
500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks
干预措施: Rhus Coriaria L. (Rhus) (Drug)
结局指标
主要结局
Serum total cholesterol level
时间窗: 6 weeks
Serum triglyceride level
时间窗: 6 weeks
Serum HDL-cholesterol level
时间窗: 6 weeks
次要结局
- Serum LDL-cholesterol level(6 weeks)
- Fasting Blood Sugar (FBS)(6 weeks)
- Serum creatinin level(6 weeks)
- Serum ALT level(6 weeks)
- Serum AST level(6 weeks)
- Serum alkaline phosphatase level(6 weeks)
- Number of patients with adverse events(10 weeks)
研究者
Mesbah Shams, MD
Associate professor of Internal Medicine & Endocrinology
Shiraz University of Medical Sciences