Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-31 @ 5:13 PM
Study NCT ID:
NCT02295293
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-04', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum total cholesterol level', 'timeFrame': '6 weeks'}, {'measure': 'Serum triglyceride level', 'timeFrame': '6 weeks'}, {'measure': 'Serum HDL-cholesterol level', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum LDL-cholesterol level', 'timeFrame': '6 weeks'}, {'measure': 'Fasting Blood Sugar (FBS)', 'timeFrame': '6 weeks'}, {'measure': 'Serum creatinin level', 'timeFrame': '6 weeks'}, {'measure': 'Serum ALT level', 'timeFrame': '6 weeks'}, {'measure': 'Serum AST level', 'timeFrame': '6 weeks'}, {'measure': 'Serum alkaline phosphatase level', 'timeFrame': '6 weeks'}, {'measure': 'Number of patients with adverse events', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rhus', 'Cholesterol', 'Triglycerides', 'Lipids', 'Medicine, Traditional', 'Herbal medicine'], 'conditions': ['Hyperlipidemias']}, 'referencesModule': {'references': [{'pmid': '29397092', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nRhus 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).\n\nIn 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-65 years\n* Serum triglyceride \\>150mg/dl AND/OR total cholesterol \\>= 240mg/dl\n\nExclusion Criteria:\n\n* Serum triglyceride \\> 500 mg/dl\n* Serum LDL-cholesterol at level which need drug treatment according to the patient risk categories (NCEP-ATP III)\n* Diabetes mellitus\n* Hypo. or hyperthyroidism\n* Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure\n* Use of drugs: OCPs, lipid lowering agents, thiazides\n* Pregnancy\n* Alcoholism\n* History of allergic reaction to Somagh'}, 'identificationModule': {'nctId': 'NCT02295293', 'acronym': 'SomaghLipid', 'briefTitle': 'The Effects of Rhus Coriaria L. on Serum Lipid Levels of Patients With Hyperlipidemia', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'The Effects of Rhus Coriaria L. (Rhus or Somagh) on Serum Lipid Levels of Patients With Hyperlipidemia', 'orgStudyIdInfo': {'id': 'CT-P-92-5581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rhus', 'description': '500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks', 'interventionNames': ['Drug: Rhus Coriaria L. (Rhus)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule: 1 capsule twice daily for 6 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rhus Coriaria L. (Rhus)', 'type': 'DRUG', 'description': '500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks', 'armGroupLabels': ['Rhus']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule: 1 capsule twice daily for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shahid Motahhari Clinic, Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Mesbah Shams, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran'}, {'name': 'Majid Nimruzi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran'}, {'name': 'Pooya Faridi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran'}, {'name': 'Mojtaba Heydari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Internal Medicine & Endocrinology', 'investigatorFullName': 'Mesbah Shams, MD', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}