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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: Rhus Coriaria L. (Rhus); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Study Chair: Mesbah Shams, M.D., Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Principal Investigator: Majid Nimruzi, M.D., Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Principal Investigator: Pooya Faridi, PhD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Principal Investigator: Mojtaba Heydari, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Publications and helpful links

General Publications

• Hajmohammadi Z, Heydari M, Nimrouzi M, Faridi P, Zibaeenezhad MJ, Omrani GR, Shams M. Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: a double-blind placebo-controlled randomized clinical trial. J Integr Med. 2018 Jan;16(1):45-50. doi: 10.1016/j.joim.2017.12.007. Epub 2017 Dec 14.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 4, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Cholesterol; Lipids; Triglycerides; Herbal medicine; Rhus; Medicine, Traditional
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: CT-P-92-5581