NCT02295293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

November 10, 2014

Last Update Submit

June 4, 2016

Conditions

Hyperlipidemias

Keywords

RhusCholesterolTriglyceridesLipidsMedicine, TraditionalHerbal medicine

Outcome Measures

Primary Outcomes (3)

  • Serum total cholesterol level

    6 weeks

  • Serum triglyceride level

    6 weeks

  • Serum HDL-cholesterol level

    6 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Rhus

EXPERIMENTAL

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

Drug: Rhus Coriaria L. (Rhus)

Placebo

PLACEBO COMPARATOR

Placebo capsule: 1 capsule twice daily for 6 weeks

Drug: Placebo

Interventions

Rhus Coriaria L. (Rhus)DRUG

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

Rhus
PlaceboDRUG

Placebo capsule: 1 capsule twice daily for 6 weeks

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20-65 years
  • Serum triglyceride \>150mg/dl AND/OR total cholesterol \>= 240mg/dl

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Related Publications (1)

  • 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.

    PMID: 29397092DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mesbah Shams, M.D.

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Internal Medicine & Endocrinology

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 20, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

IR(1)