The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Drug: Rhus Coriaria L. (Rhus)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 20-65 years Serum triglyceride >150mg/dl AND/OR total cholesterol >= 240mg/dl Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhus<br>500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks | Drug: Rhus Coriaria L. (Rhus)<br>* 500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo capsule: 1 capsule twice daily for 6 weeks | Drug: Placebo<br>* Placebo capsule: 1 capsule twice daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total cholesterol level |  | 6 weeks | 
| Serum triglyceride level |  | 6 weeks | 
| Serum HDL-cholesterol level |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhus, Cholesterol, Triglycerides, Lipids, Medicine, Traditional, Herbal medicine