HyperlipidemiasEarly Phase 1SomaghLipidNCT02295293
The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia
A Early Phase 1 study testing Rhus Coriaria L. (Rhus) in people with Hyperlipidemias, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Rhus Coriaria L. (Rhus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- Dec 2014to May 2015
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-65 years
- Serum triglyceride >150mg/dl AND/OR total cholesterol >= 240mg/dl
Who cannot join
- 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
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- Pregnancy
- Alcoholism
- 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
About this study
Official title: The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia
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.
Read the detailed description
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, antidiarrhetic, antiseptic, anorexic and antihypergylcemic 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.Moreover, the hypocholesterolemic action of dietary polyphenols has been reported. The hypocholesterolemic effect of Rhus fruit powder and its components have been reported previously in rabbits and mice.
- Conditions
- Hyperlipidemias
- Being tested
- Rhus Coriaria L. (Rhus), Placebo
- Keywords
- Rhus, Cholesterol, Triglycerides, Lipids, Medicine, Traditional, Herbal medicine
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhus Coriaria L. (Rhus)Drug
500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks
PlaceboDrug
Placebo capsule: 1 capsule twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rhus | Experimental | 500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks Receives: Drug: Rhus Coriaria L. (Rhus) |
| Placebo | Placebo comparator | Placebo capsule: 1 capsule twice daily for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum total cholesterol level
Measured: 6 weeks
Serum triglyceride level
Measured: 6 weeks
Serum HDL-cholesterol level
Measured: 6 weeks
Secondary outcomes (7)
Serum LDL-cholesterol level
Measured: 6 weeks
Fasting Blood Sugar (FBS)
Measured: 6 weeks
Serum creatinin level
Measured: 6 weeks
Serum ALT level
Measured: 6 weeks
Serum AST level
Measured: 6 weeks
Serum alkaline phosphatase level
Measured: 6 weeks
Number of patients with adverse events
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
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
- Mesbah Shams, M.D., Study chair, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, IranMajid Nimruzi, M.D., Principal investigator, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, IranPooya Faridi, PhD, Principal investigator, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, IranMojtaba Heydari, MD, Principal investigator, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295293
- Sponsor's protocol ID
- CT-P-92-5581
- Acronym
- SomaghLipid
- Status last verified
- Jun 2016
- First submitted
- 10 Nov 2014
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29397092
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT02295293
- Acronym / sponsor ID
- SomaghLipid / CT-P-92-5581
- Conditions
- Hyperlipidemias
- Keywords
- Rhus, Cholesterol, Triglycerides, Lipids, Medicine, Traditional, Herbal medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Nov 2014 (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.
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.
Detailed description
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, antidiarrhetic, antiseptic, anorexic and antihypergylcemic 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.Moreover, the hypocholesterolemic action of dietary polyphenols has been reported. The hypocholesterolemic effect of Rhus fruit powder and its components have been reported previously in rabbits and mice.
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 | Experimental | Drug: Rhus Coriaria L. (Rhus)500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule: 1 capsule twice daily for 6 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 20-65 years
- Serum triglyceride >150mg/dl AND/OR total cholesterol >= 240mg/dl
Key exclusion criteria (9 listed)
- 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
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 Coriaria L. (Rhus)500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks | Drug | Rhus |
| PlaceboPlacebo capsule: 1 capsule twice daily for 6 weeks | Drug | Placebo |
Primary outcome
Serum total cholesterol level
Time frame: 6 weeks
Serum triglyceride level
Time frame: 6 weeks
Serum HDL-cholesterol level
Time frame: 6 weeks
7 secondary outcomes
Serum LDL-cholesterol level
Time frame: 6 weeks
Fasting Blood Sugar (FBS)
Time frame: 6 weeks
Serum creatinin level
Time frame: 6 weeks
Serum ALT level
Time frame: 6 weeks
Serum AST level
Time frame: 6 weeks
Serum alkaline phosphatase level
Time frame: 6 weeks
Number of patients with adverse events
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Derived from this study: PubMed 29397092Hajmohammadi 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.
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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.
Mesbah Shams, M.D. study chair
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Majid Nimruzi, M.D. principal investigator
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
Pooya Faridi, PhD principal investigator
Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rhus Coriaria L. (Rhus) in people with Hyperlipidemias, 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 2 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: finished, as of the sponsor's last update on 7 Jun 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum total cholesterol level (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295293, which also lists 1 linked publication.
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 7 Jun 2016.