Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-12 @ 11:18 PM
Study NCT ID:
NCT06591767
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2024-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quercetin as Possible Supportive Therapy for Mild to Moderate Hyperuricemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011794', 'term': 'Quercetin'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-09-08', 'studyFirstSubmitQcDate': '2024-09-08', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on circulatory uric acid', 'timeFrame': '90 days', 'description': 'Change in plasma uric acid level'}], 'secondaryOutcomes': [{'measure': 'Effect on lipids', 'timeFrame': '90 days', 'description': 'Change in plasma cholesterol level'}, {'measure': 'Effect on lipids', 'timeFrame': '90 days', 'description': 'Change in plasma triglycerides level'}, {'measure': 'Effect on glycemia', 'timeFrame': '90 days', 'description': 'Change in plasma glucose level'}, {'measure': 'Effect on glycemia', 'timeFrame': '90 days', 'description': 'Change in plasma insulin level'}, {'measure': 'Effect on body internal organs muscles', 'timeFrame': '90 days', 'description': 'Change in the Creatine Phosphokinase (CPK) levels'}, {'measure': 'Effect on liver function', 'timeFrame': '90 days', 'description': 'Change in the Alanine Aminotransferase levels'}, {'measure': 'Effect on liver function', 'timeFrame': '90 days', 'description': 'Change in the Aspartate Aminotransferase levels'}, {'measure': 'Effect on liver function', 'timeFrame': '90 days', 'description': 'Change in the Alkaline Phosphatase levels'}, {'measure': 'Effect on liver function', 'timeFrame': '90 days', 'description': 'Change in the Gamma-Glutamyl Transferase levels'}, {'measure': 'Effect on liver function', 'timeFrame': '90 days', 'description': 'Change in the Bilirubin levels'}, {'measure': 'Supplement safety and tolerability', 'timeFrame': '90 days', 'description': 'Number of patients reporting possible side effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'Uric acid, a metabolic byproduct of purine degradation in humans, is a known risk factor for conditions such as gout and type 2 diabetes. Research has shown that supplementation with quercetin can significantly reduce plasma uric acid levels in individuals with mild hyperuricemia, potentially mitigating these associated risks.', 'detailedDescription': 'Uric acid, a metabolic byproduct of purine degradation in humans, is a significant risk factor for the development of gout and type 2 diabetes. Supplementation with quercetin, a flavonol not naturally produced by the human body, has been shown to significantly reduce plasma uric acid levels in individuals with mild hyperuricemia. This effect is primarily achieved through the inhibition of xanthine oxidoreductase, an enzyme crucial to uric acid production.\n\nQuercetin is the most abundant polyphenol found in fruits and vegetables and is widely used as a dietary supplement to boost the immune system and promote overall health. It is characterized by three key properties: antioxidant, anti-inflammatory, and immunomodulatory. These combined actions make quercetin a promising candidate for supporting various health conditions where oxidative stress, inflammation, and immune function play a role, including cardiovascular health, healthy aging, bone and joint health, sports and physical activity, gut health, and respiratory well-being.\n\nThe above-described properties of quercetin prompted investigators to explore its potential uricosuric therapeutic effect in two clinical studies. The first study will assess this effect in a retrospective cohort of COVID-19 patients who received quercetin as a supplemental therapy. In the second study, its potential uricosuric therapeutic effect will be assessed in a randomized controlled prospective clinical trial involving patients with mild to moderate hyperuricemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Aged between 18 and 75 years.\n* Diagnosed with obesity.\n* Diagnosed with hypercholesterolemia.\n* With or without moderate hyperuricemia (serum uric acid ≥ 8 mg/dL).\n* No restrictions on BMI, alcohol consumption, or smoking habits.\n\nExclusion criteria:\n\n* Current use of uric acid-lowering medications (e.g., allopurinol, febuxostat).\n* Diagnosed with oncological diseases.\n* Diagnosed with neurological diseases.\n* Diagnosed with inflammatory bowel diseases.'}, 'identificationModule': {'nctId': 'NCT06591767', 'briefTitle': 'Quercetin as Possible Supportive Therapy for Mild to Moderate Hyperuricemia', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat University of Medical & Health Sciences'}, 'officialTitle': 'Potential Pharmacological Effects of Supplemental Quercetin in the Management of Mild to Moderate Hyperuricemia', 'orgStudyIdInfo': {'id': '88_18.01.2023_QuercetinFit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quercetin group', 'description': 'In this group hyperuricemic patients (uric acid \\> 8 mg/dL) received oral supplemental Quercetin, twice a day for 90 days.', 'interventionNames': ['Dietary Supplement: Quercetin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group 1', 'description': 'In this group hyperuricemic patients (uric acid \\> 8 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days.', 'interventionNames': ['Combination Product: Berberol K®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group 2', 'description': 'In this group normouricemic patients (uric acid \\< 7 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days.', 'interventionNames': ['Combination Product: Berberol K®']}], 'interventions': [{'name': 'Quercetin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Quevir®'], 'description': '200 mg supplemental Quercefit®', 'armGroupLabels': ['Quercetin group']}, {'name': 'Berberol K®', 'type': 'COMBINATION_PRODUCT', 'description': 'Berberine Phytosome® 730 mg\n\n\\+ MonakoPure® containing 2.9 mg of monacolin K and KA from red yeast rice extract', 'armGroupLabels': ['Control group 1', 'Control group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'country': 'Italy', 'facility': 'S. Orsola-Malpighi Polyclinic Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat University of Medical & Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Urbino "Carlo Bo"', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Biochemistry and Experimental Medicine', 'investigatorFullName': 'Dr. Amjad Khan', 'investigatorAffiliation': 'Liaquat University of Medical & Health Sciences'}}}}