The Effects of Rhus Coriaria L. on Serum Uric Acid Levels (SomaghUricA)
Primary Purpose
Hyperuricemia
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Rhus (Somagh)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia focused on measuring Rhus, Medicine, Traditional, Herbal medicine, Uric acid
Eligibility Criteria
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
Sites / Locations
- Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rhus (Somagh)
Placebo
Arm Description
500 mg twice daily after meal for 6 weeks
500 mg twice daily after meal for 6 weeks
Outcomes
Primary Outcome Measures
serum uric acid levels
Secondary Outcome Measures
Number of patients with adverse events.
Full Information
NCT ID
NCT02891031
First Posted
August 31, 2016
Last Updated
April 4, 2019
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02891031
Brief Title
The Effects of Rhus Coriaria L. on Serum Uric Acid Levels
Acronym
SomaghUricA
Official Title
The Effects of Rhus Coriaria L. on Serum Uric Acid Levels
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
Keywords
Rhus, Medicine, Traditional, Herbal medicine, Uric acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rhus (Somagh)
Arm Type
Active Comparator
Arm Description
500 mg twice daily after meal for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg twice daily after meal for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Rhus (Somagh)
Other Intervention Name(s)
Somagh
Intervention Description
500 mg twice daily after meal for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mg twice daily after meal for 6 weeks
Primary Outcome Measure Information:
Title
serum uric acid levels
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of patients with adverse events.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mesbah Shams, MD
Phone
+98-71-36474316
Email
shams@sums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gholamhossein Ranjbar Omrani, MD
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seiyed Mohammad Hosseini-Saadi, MD
Organizational Affiliation
Department of Internal Medicine, Shiraz University of Medical Sciences
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mesbah Shams, M.D.
Phone
+989171115134
Email
shams@sums.ac.ir
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Rhus Coriaria L. on Serum Uric Acid Levels
We'll reach out to this number within 24 hrs