Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06002893
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cholesfytol NG®) supplement treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood lipid profile', 'timeFrame': '2-months', 'description': 'Decrease in blood total cholesterol (TC) concentration'}, {'measure': 'Change in blood lipid profile', 'timeFrame': '2-months', 'description': 'Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration'}, {'measure': 'Change in blood lipid profile', 'timeFrame': '2-months', 'description': 'Decrease in blood triglycerides (TG) concentration'}, {'measure': 'Change in blood lipid profile', 'timeFrame': '2-months', 'description': 'Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration'}, {'measure': 'Decrease in blood lipid profile', 'timeFrame': '2-months', 'description': 'Change in blood remnant cholesterol (RC) concentration'}], 'secondaryOutcomes': [{'measure': 'Rate of side effects', 'timeFrame': '2-months', 'description': 'Number of patients reporting myalgia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '38089061', 'type': 'DERIVED', 'citation': 'Hermans MP, Dierckxsens Y, Janssens I, Seidel L, Albert A, Ahn SA, Rousseau MF, Khan A. The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia. Front Pharmacol. 2023 Nov 27;14:1280234. doi: 10.3389/fphar.2023.1280234. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.', 'detailedDescription': "The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 21 years\n* Both male or female\n* Blood total cholesterol (TC) level ≥ 200 mg/dL\n* Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL\n* With or without myalgia and/or diabetes\n* No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol- lowering treatment did not allow them to reach LDL-C target\n* Patients who had stopped their cholesterol-lowering treatment because of side effects including myalgia\n\nExclusion Criteria:\n\n* Pregnant nor breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT06002893', 'briefTitle': 'The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat University of Medical & Health Sciences'}, 'officialTitle': 'The Antihypercholestrolemic Pharmacological Effect of a Combined Supplement of Amla Fruit, Walnut Leaves, Red Yeast Rice, and Olive Fruit Extracts Leads to Improvement in Circulatory Levels of LDL-C and Remnant Cholesterol', 'orgStudyIdInfo': {'id': 'AK/08.08.2023/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cholesfytol NG®) supplement', 'description': 'Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NG®) supplement for 2-months.', 'interventionNames': ['Dietary Supplement: Cholesfytol NG®) supplement']}], 'interventions': [{'name': 'Cholesfytol NG®) supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'General Practitioner (GP) prescribed oral Cholesfytol NG®) supplement', 'armGroupLabels': ['Cholesfytol NG®) supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat University of Medical & Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', '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'}}}}