The Effects of Rhus Coriaria L. on Serum Uric Acid Levels (SomaghUricA)

The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on serum uric acid levels.

Study Overview

• Status: Unknown
• Conditions: Hyperuricemia
• Intervention / Treatment: Drug: Rhus (Somagh); Drug: Placebo

Detailed Description

Rhus coriaria L.(Rhus) is a well-known spice widely consumed in the world which has also been utilized extensively for medicinal purposes. The antioxidant components of this plant made it a favorable target for laboratory and animal studies in different conditions such as oxidative stress cytotoxicity, diabetes and hyperlipidemia. 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, antidiarrheic, antiseptic, anorexic and antihyperglycemic 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.

Uric acid (UA; 7,9-dihydro-1H-purine-2,6,8(3H)-trione) has been implicated as a risk factor and cause of numerous disease states. Some disease states, such as gout, hypertension, and cardiovascular disease, have been shown to result when UA levels in the blood are too high. Hyperuricemia predicts the development of hypertension in the general population, and an independent positive correlation between UA levels and the occurrence of hypertension has been reported. Hyperuricemia may also be a risk factor for cardiovascular disease, myocardial infarction, and stroke.

The manipulation of serum UA levels has become a popular strategy in the treatment of a variety of diseases. This is either accomplished through dietary and lifestyle changes or through treatment with UA reducing drugs.

The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as Somagh on serum uric acid levels.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mesbah Shams, MD; Phone Number: +98-71-36474316; Email: shams@sums.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shahid Motahhari Clinic, Shiraz University of Medical Sciences
      • Contact: Mesbah Shams, M.D.; Phone Number: +989171115134; Email: shams@sums.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy individuals

Exclusion Criteria:

• Serum uric acid levels that need medical treatment
• Gout
• Diabetes mellitus
• Hypo. or hyperthyroidism
• Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure
• Use of drugs: Uric acid lowering agents
• Pregnancy
• Lactation
• History of allergic reaction to Somagh

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rhus (Somagh); 500 mg twice daily after meal for 6 weeks	Drug: Rhus (Somagh); 500 mg twice daily after meal for 6 weeks; Other Names: Somagh
Placebo Comparator: Placebo; 500 mg twice daily after meal for 6 weeks	Drug: Placebo; 500 mg twice daily after meal for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum uric acid levels	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events.	6 weeks

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: Gholamhossein Ranjbar Omrani, MD, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences; Principal Investigator: Seiyed Mohammad Hosseini-Saadi, MD, Department of Internal Medicine, Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Uric acid; Herbal medicine; Rhus; Medicine, Traditional
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: 11541-01-01-95

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No