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

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Rhus Coriaria L. (Rhus)
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias focused on measuring Rhus, Cholesterol, Triglycerides, Lipids, Medicine, Traditional, Herbal medicine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rhus

Placebo

Arm Description

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

Placebo capsule: 1 capsule twice daily for 6 weeks

Outcomes

Primary Outcome Measures

Serum total cholesterol level
Serum triglyceride level
Serum HDL-cholesterol level

Secondary Outcome Measures

Serum LDL-cholesterol level
Fasting Blood Sugar (FBS)
Serum creatinin level
Serum ALT level
Serum AST level
Serum alkaline phosphatase level
Number of patients with adverse events

Full Information

First Posted
November 10, 2014
Last Updated
June 4, 2016
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02295293
Brief Title
The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia
Acronym
SomaghLipid
Official Title
The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Rhus, Cholesterol, Triglycerides, Lipids, Medicine, Traditional, Herbal medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhus
Arm Type
Experimental
Arm Description
500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule: 1 capsule twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Rhus Coriaria L. (Rhus)
Intervention Description
500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule: 1 capsule twice daily for 6 weeks
Primary Outcome Measure Information:
Title
Serum total cholesterol level
Time Frame
6 weeks
Title
Serum triglyceride level
Time Frame
6 weeks
Title
Serum HDL-cholesterol level
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Serum LDL-cholesterol level
Time Frame
6 weeks
Title
Fasting Blood Sugar (FBS)
Time Frame
6 weeks
Title
Serum creatinin level
Time Frame
6 weeks
Title
Serum ALT level
Time Frame
6 weeks
Title
Serum AST level
Time Frame
6 weeks
Title
Serum alkaline phosphatase level
Time Frame
6 weeks
Title
Number of patients with adverse events
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mesbah Shams, M.D.
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Majid Nimruzi, M.D.
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pooya Faridi, PhD
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mojtaba Heydari, MD
Organizational Affiliation
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29397092
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.
Results Reference
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The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia

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