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

Shiraz University of Medical Sciences

Status and phase: Completed; Early Phase 1

Conditions: Hyperlipidemias

Treatments: Drug: Placebo; Drug: Rhus Coriaria L. (Rhus)

Study type: Interventional

Funder types: Other

Identifiers

NCT02295293

CT-P-92-5581

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Rhus

Experimental group

Description:

500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks

Treatment:

Drug: Rhus Coriaria L. (Rhus)

Placebo

Placebo Comparator group

Description:

Placebo capsule: 1 capsule twice daily for 6 weeks

Treatment:

Drug: Placebo