Clinical trial NCT02295293: The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia
Official title: The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperlipidemias
Keywords: Rhus
Cholesterol
Triglycerides
Lipids
Medicine, Traditional
Herbal medicine
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum total cholesterol level
timeFrame: 6 weeks
measure: Serum triglyceride level
timeFrame: 6 weeks
measure: Serum HDL-cholesterol level
timeFrame: 6 weeks
Secondary outcomes:
measure: Serum LDL-cholesterol level
timeFrame: 6 weeks
measure: Fasting Blood Sugar (FBS)
timeFrame: 6 weeks
measure: Serum creatinin level
timeFrame: 6 weeks
measure: Serum ALT level
timeFrame: 6 weeks
measure: Serum AST level
timeFrame: 6 weeks
measure: Serum alkaline phosphatase level
timeFrame: 6 weeks
measure: Number of patients with adverse events
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shahid Motahhari Clinic, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
name: Mesbah Shams, M.D.
role: STUDY_CHAIR
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
name: Majid Nimruzi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
name: Pooya Faridi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
name: Mojtaba Heydari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.