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

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02891031
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rhus (Somagh)
  • Drug: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
76 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. on Serum Uric Acid Levels
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. serum uric acid levels [6 weeks]

    Secondary Outcome Measures

    1. Number of patients with adverse events. [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shahid Motahhari Clinic, Shiraz University of Medical Sciences Shiraz Fars Iran, Islamic Republic of

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mesbah Shams, MD, Associate professor of Internal medicine and Endocrinology, Shiraz University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02891031
    Other Study ID Numbers:
    • 11541-01-01-95
    First Posted:
    Sep 7, 2016
    Last Update Posted:
    Apr 8, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mesbah Shams, MD, Associate professor of Internal medicine and Endocrinology, Shiraz University of Medical Sciences
    Rhus
    Medicine, Traditional
    Herbal medicine
    Uric acid
    Additional relevant MeSH terms:
    Hyperuricemia

    Study Results

    No Results Posted as of Apr 8, 2019