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

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02295293

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias	Drug: Rhus Coriaria L. (Rhus) Drug: Placebo	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum total cholesterol level [6 weeks]
Serum triglyceride level [6 weeks]
Serum HDL-cholesterol level [6 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars	Iran, Islamic Republic of

Sponsors and Collaborators

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