HyperuricemiaSomaghUricANCT02891031
The Effects of Rhus Coriaria L. on Serum Uric Acid Levels
A study testing Rhus (Somagh) in people with Hyperuricemia, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Rhus (Somagh)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Lactation
- History of allergic reaction to Somagh
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
Mesbah Shams, M.D., +989171115134, shams@sums.ac.ir
About this study
The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on serum uric acid levels.
Read the 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.
- Conditions
- Hyperuricemia
- Being tested
- Rhus (Somagh), Placebo
- Keywords
- Rhus, Medicine, Traditional, Herbal medicine, Uric acid
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhus (Somagh)Drug
Also called Somagh
500 mg twice daily after meal for 6 weeks
PlaceboDrug
500 mg twice daily after meal for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rhus (Somagh) | Active comparator | 500 mg twice daily after meal for 6 weeks Receives: Drug: Rhus (Somagh) |
| Placebo | Placebo comparator | 500 mg twice daily after meal for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum uric acid levels
Measured: 6 weeks
Secondary outcomes (1)
Number of patients with adverse events.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start1 Jun 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Gholamhossein Ranjbar Omrani, MD, Principal investigator, Endocrine and Metabolism Research Center, Shiraz University of Medical SciencesSeiyed Mohammad Hosseini-Saadi, MD, Principal investigator, Department of Internal Medicine, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891031
- Sponsor's protocol ID
- 11541-01-01-95
- Acronym
- SomaghUricA
- Status last verified
- Apr 2019
- First submitted
- 31 Aug 2016
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rhus Coriaria L. on Serum Uric Acid Levels
- ClinicalTrials.gov ID
- NCT02891031
- Acronym / sponsor ID
- SomaghUricA / 11541-01-01-95
- Conditions
- Hyperuricemia
- Keywords
- Rhus, Medicine, Traditional, Herbal medicine, Uric acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhus (Somagh) | Active comparator | Drug: Rhus (Somagh)500 mg twice daily after meal for 6 weeks |
| Placebo | Placebo comparator | Drug: Placebo500 mg twice daily after meal for 6 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhus (Somagh)Also: Somagh500 mg twice daily after meal for 6 weeks | Drug | Rhus (Somagh) |
| Placebo500 mg twice daily after meal for 6 weeks | Drug | Placebo |
Primary outcome
serum uric acid levels
Time frame: 6 weeks
1 secondary outcome
Number of patients with adverse events.
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gholamhossein Ranjbar Omrani, MD principal investigator
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Seiyed Mohammad Hosseini-Saadi, MD principal investigator
Department of Internal Medicine, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhus (Somagh) in people with Hyperuricemia, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mesbah Shams, MD (+98-71-36474316, shams@sums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum uric acid levels (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.