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

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ClinicalTrials.gov Identifier: NCT02295293
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Mesbah Shams, MD, 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.


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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

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




Primary Outcome Measures :
  1. Serum total cholesterol level [ Time Frame: 6 weeks ]
  2. Serum triglyceride level [ Time Frame: 6 weeks ]
  3. Serum HDL-cholesterol level [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Serum LDL-cholesterol level [ Time Frame: 6 weeks ]
  2. Fasting Blood Sugar (FBS) [ Time Frame: 6 weeks ]
  3. Serum creatinin level [ Time Frame: 6 weeks ]
  4. Serum ALT level [ Time Frame: 6 weeks ]
  5. Serum AST level [ Time Frame: 6 weeks ]
  6. Serum alkaline phosphatase level [ Time Frame: 6 weeks ]
  7. Number of patients with adverse events [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295293


Locations
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Iran, Islamic Republic of
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mesbah Shams, MD, Associate professor of Internal Medicine & Endocrinology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02295293    
Other Study ID Numbers: CT-P-92-5581
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Keywords provided by Mesbah Shams, MD, Shiraz University of Medical Sciences:
Rhus
Cholesterol
Triglycerides
Lipids
Medicine, Traditional
Herbal medicine
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases