Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT07013058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to receive either Nisatol® (Nigella sativa extract) or follow a Mediterranean diet for 4 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fasting Blood Glucose', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of the change in fasting blood glucose from baseline to 4 months.'}, {'measure': 'Change in Total Cholesterol levels, (mg/dL)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of total cholesterol from baseline to 4 months.'}, {'measure': 'Change in low-density lipoprotein cholesterol levels, (mg/dL)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of low-density lipoprotein cholesterol from baseline to 4 months.'}, {'measure': 'Change in high-density lipoprotein cholesterol levels, (mg/dL)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of high-density lipoprotein cholesterol from baseline to 4 months.'}, {'measure': 'Change in Triglycerides levels, (mg/dL)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of triglyceride levels from baseline to 4 months.'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of the change in systolic and diastolic blood pressure from baseline to 4 months.'}, {'measure': 'Change in Serum Cortisol levels, (μg/dL)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of Cortisol levels from baseline to 4 months.'}, {'measure': 'Change in Serum Uric Acid levels, (mg/dL)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of Uric acid levels from baseline to 4 months.'}, {'measure': 'Change in serum Alanine Aminotransferase Enzyme levels, (U/L)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of Alanine Aminotransferase Enzyme levels from baseline to 4 months.'}, {'measure': 'Change in serum Aspartate Aminotransferase Enzyme levels, (U/L)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of Aspartate Aminotransferase Enzyme levels from baseline to 4 months.'}, {'measure': 'Change in serum Change in Serum Creatinine levels, (mg/dL or µmol/L)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of serum creatinine from baseline to 4 months.'}, {'measure': 'Change in serum Creatine Phosphokinase Enzymes levels, (U/L)', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation of Creatine Phosphokinase Enzymes levels from baseline to 4 months.'}, {'measure': 'Change in Climacteric Symptoms', 'timeFrame': 'Baseline to 4 months', 'description': 'Evaluation using the Greene Climacteric Scale, a 21-item self-reported questionnaire where each item is rated from 0 (not at all) to 3 (extremely), with a total score range from 0 to 63. Higher scores indicate more severe symptoms. Changes will be measured from baseline to 4 months.'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'Throughout study duration (4 months)', 'description': 'Evaluation of adverse events, tolerability score (0-10), and adherence rate (%) over the 4-month treatment period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome', 'Elevated Blood Pressure']}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter, randomized controlled study evaluating the efficacy and safety of a Nigella sativa extract standardized to 10% thymoquinone (Nisatol®) in perimenopausal women with metabolic syndrome. The study will assess changes in metabolic and blood pressure parameters, as well as improvements in menopausal symptoms and quality of life.', 'detailedDescription': 'This prospective, multicenter, randomized controlled clinical trial aims to evaluate the efficacy and safety of a food supplement containing Nigella sativa oil standardized to 10% thymoquinone (Nisatol®) in perimenopausal women diagnosed with metabolic syndrome and experiencing climacteric symptoms.\n\nFifty participants will be randomly assigned to either the intervention group (receiving 2 softgel capsules of Nisatol® daily for 4 months) or a control group following a Mediterranean diet. The primary endpoint is the change from baseline in metabolic and blood pressure parameters, including fasting glucose, lipid profile, cortisolemia, uricemia, and systolic/diastolic blood pressure. The study will also assess quality of life using the Greene Climacteric Scale and monitor treatment safety and tolerability.\n\nThe study addresses the need for non-hormonal, evidence-based interventions for managing metabolic and menopausal symptoms in midlife women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Perimenopausal women aged 40-60 years\n* Presence of climacteric (menopausal) symptoms\n* Diagnosis of metabolic syndrome, defined as alteration of at least 3 of the following:\n\n * Systolic blood pressure ≥130 mmHg and/or diastolic ≥85 mmHg\n * HDL cholesterol \\<50 mg/dL\n * Triglycerides ≥150 mg/dL\n * Fasting blood glucose ≥100 mg/dL\n * Uricemia \\>7 mg/dL\n\nExclusion Criteria:\n\n* Use of hormone replacement therapy (HRT)\n* Presence of neoplastic diseases\n* Presence of liver disease, kidney failure, or diabetes mellitus\n* Drug or alcohol abuse\n* Known hypersensitivity to Nigella sativa or any formulation component'}, 'identificationModule': {'nctId': 'NCT07013058', 'briefTitle': 'Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat University of Medical & Health Sciences'}, 'officialTitle': 'Evaluation of the Efficacy of a Nigella Sativa Extract Standardized to 10% Thymoquinone (Nisatol®) in Improving Metabolic and Blood Pressure Parameters and Quality of Life in Perimenopausal Women With Metabolic Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '134_21May2025_NISATOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nisatol® Supplement Group', 'description': 'Participants in this arm will receive 2 softgel capsules per day of Nigella sativa oil standardized to 10% thymoquinone (Nisatol®), one capsule with lunch and one with dinner, for a total duration of 4 months.', 'interventionNames': ['Dietary Supplement: Nigella sativa extract (Nisatol®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean Diet Group', 'description': 'Participants in this arm will follow a Mediterranean diet for 4 months. No Nigella sativa supplement will be administered.', 'interventionNames': ['Behavioral: Mediterranean Diet']}], 'interventions': [{'name': 'Nigella sativa extract (Nisatol®)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take 2 softgel capsules daily of Nigella sativa oil standardized to 10% thymoquinone (Nisatol®), one capsule with lunch and one with dinner, for 4 months.', 'armGroupLabels': ['Nisatol® Supplement Group']}, {'name': 'Mediterranean Diet', 'type': 'BEHAVIORAL', 'description': 'Participants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation.', 'armGroupLabels': ['Mediterranean Diet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03100', 'city': 'Frosinone', 'country': 'Italy', 'contacts': [{'name': 'Dr. Francesco Di Pierro, PhD', 'role': 'CONTACT', 'email': 'amjadkhan@lumhs.edu.pk'}], 'facility': 'ASL Frosinone, Dipartimento di Prevenzione,', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}