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

Hyperlipidemias Clinical Trial

— SomaghLipid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295293
• Other study ID #: CT-P-92-5581
• Status: Completed
• Phase: Phase 0
• First received: November 10, 2014
• Last updated: June 4, 2016
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum total cholesterol level		6 weeks	Yes
Primary	Serum triglyceride level		6 weeks	Yes
Primary	Serum HDL-cholesterol level		6 weeks	Yes
Secondary	Serum LDL-cholesterol level		6 weeks	Yes
Secondary	Fasting Blood Sugar (FBS)		6 weeks	Yes
Secondary	Serum creatinin level		6 weeks	Yes
Secondary	Serum ALT level		6 weeks	Yes
Secondary	Serum AST level		6 weeks	Yes
Secondary	Serum alkaline phosphatase level		6 weeks	Yes
Secondary	Number of patients with adverse events		10 weeks	Yes