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

Early Phase 1
Completed
Conditions
Hyperlipidemias
Interventions
Drug: Rhus Coriaria L. (Rhus)
Drug: Placebo
Registration Number
NCT02295293
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
74
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RhusRhus Coriaria L. (Rhus)500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks
PlaceboPlaceboPlacebo capsule: 1 capsule twice daily for 6 weeks
Primary Outcome Measures
NameTimeMethod
Serum total cholesterol level6 weeks
Serum triglyceride level6 weeks
Serum HDL-cholesterol level6 weeks
Secondary Outcome Measures
NameTimeMethod
Serum LDL-cholesterol level6 weeks
Fasting Blood Sugar (FBS)6 weeks
Serum creatinin level6 weeks
Serum ALT level6 weeks
Serum AST level6 weeks
Serum alkaline phosphatase level6 weeks
Number of patients with adverse events10 weeks

Trial Locations

Locations (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

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Shiraz, Fars, Iran, Islamic Republic of

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