Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT06972134
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012715', 'term': 'Sesame Oil'}, {'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D011620', 'term': 'Psyllium'}, {'id': 'C018655', 'term': 'Rowachol'}, {'id': 'D013729', 'term': 'Terpenes'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gallstone Dissolution Rate', 'timeFrame': '48-hours, 96-hours, 144 hours', 'description': 'Percentage reduction in gallstone weight after treatment.\n\nCalculated using the formula:\n\nDR%= (W initial-W final)/ W initial×100 Measurement Tool: Ohaus Adventurer Pro AV-2102 balance Unit of Measure: %'}, {'measure': 'Cholesterol Release', 'timeFrame': '48-hours, 96-hours, 144 hours', 'description': 'Total cholesterol released from gallstones into the dissolving medium. Measurement Tool: Cholestech LX-20 autoanalyzer Unit of Measure: mg'}], 'secondaryOutcomes': [{'measure': 'Bioactive Compound Concentration', 'timeFrame': 'Baseline (T0)', 'description': 'Quantification of key compounds (oleic acid, taraxacin, arabinoxylan, linoleic acid) in treatment solutions.\n\nMeasurement Tool: GC-MS (fatty acids), HPLC (plant extracts) Unit of Measure: mg/mL'}, {'measure': 'Synergistic Interaction Efficacy', 'timeFrame': '144 hours (T3)', 'description': 'Comparative analysis of dissolution rates and cholesterol release between combined and individual treatments.\n\nMeasurement Tool: Ohaus Balance + Cholestech LX-20 Unit of Measure: %, mg'}, {'measure': 'Correlation: Compounds vs. Outcomes', 'timeFrame': '144 hours (T3)', 'description': 'Pearson correlation coefficients between bioactive compound concentrations and dissolution metrics.\n\nMeasurement Tool: Statistical analysis (SPSS v26) Unit of Measure: r-value (unitless)'}, {'measure': 'Predictive Factors of Dissolution', 'timeFrame': '144 hours (T3)', 'description': 'Multiple regression analysis identifying key predictors (e.g., oleic acid, taraxacin) of efficacy.\n\nMeasurement Tool: Statistical analysis (SPSS v26) Unit of Measure: β-coefficient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gallstone dissolution', 'Cholesterol gallstones', 'Natural oils', 'Herbal extracts', 'Oleic Acid', 'Taraxacin', 'Rowachol®', 'In vitro study'], 'conditions': ['Cholesterol Gallstone Dissolution']}, 'referencesModule': {'references': [{'pmid': '37446683', 'type': 'BACKGROUND', 'citation': 'Fan M, Zhang X, Song H, Zhang Y. Dandelion (Taraxacum Genus): A Review of Chemical Constituents and Pharmacological Effects. Molecules. 2023 Jun 27;28(13):5022. doi: 10.3390/molecules28135022.'}, {'type': 'BACKGROUND', 'citation': 'Kumar, Pandey J, Kumar P, et al.; Psyllium Mucilage and Its Use in Pharmaceutical Field: An Overview. Current Synthetic and Systems Biology 2017;05. doi: 10.4172/2332-0737.1000134.'}, {'pmid': '39391681', 'type': 'BACKGROUND', 'citation': 'Zommara MA, Swelam S, Raya-Alvarez E, Imaizumi K, Elmahdy A, Alkhudhayri DA, Aljehani AA, Agil A, Elmahallawy EK. Nutritional and potential health benefits of chufa oil, olive oil, and anhydrous milk fat against gallstone disease in a C57BL/6N mouse model. Front Nutr. 2024 Sep 26;11:1445484. doi: 10.3389/fnut.2024.1445484. eCollection 2024.'}, {'pmid': '35804451', 'type': 'BACKGROUND', 'citation': 'Vahedi H, Atefi M, Entezari MH, Hassanzadeh A. The effect of sesame oil consumption compared to sunflower oil on lipid profile, blood pressure, and anthropometric indices in women with non-alcoholic fatty liver disease: a randomized double-blind controlled trial. Trials. 2022 Jul 8;23(1):551. doi: 10.1186/s13063-022-06451-1.'}, {'pmid': '24321208', 'type': 'BACKGROUND', 'citation': 'Stokes CS, Gluud LL, Casper M, Lammert F. Ursodeoxycholic acid and diets higher in fat prevent gallbladder stones during weight loss: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol. 2014 Jul;12(7):1090-1100.e2; quiz e61. doi: 10.1016/j.cgh.2013.11.031. Epub 2013 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nThis study aims to evaluate the effectiveness of a natural mixture (sesame oil, extra virgin olive oil, psyllium extract, and dandelion extract) in dissolving cholesterol gallstones compared to the standard medication, Rowachol®.\n\nMethods:\n\nIn laboratory experiments, 70 cholesterol gallstones obtained from 55 patients were divided into seven groups. Each group was treated with different combinations of the natural ingredients or Rowachol®. The stones were monitored for 144 hours to measure dissolution rate and cholesterol release.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\----------------------------------- Diagnosis of cholesterol gallstones requiring surgical removal. Gallstones with ≥70% cholesterol composition (confirmed via FTIR). Gallstone size: 10-13 mm (measured via digital caliper). Gallstone weight: 120-150 mg (measured via electronic balance). Age range: 40-50 years. BMI: 20-30 kg/m².\n\n\\------------------------------------------------------------------------------------------------------------------------------\n\nExclusion Criteria:\n\n\\----------------------------------- Hepatitis B/C infection. Chronic or acute illnesses (e.g., liver cirrhosis, hemolytic anemia). Pregnancy or lactation. History of malignancy. Participation in other clinical trials within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT06972134', 'briefTitle': 'Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®', 'organization': {'class': 'OTHER', 'fullName': 'University of Duhok'}, 'officialTitle': 'Synergistic Effects of Sesame Oil, Extra Virgin Olive Oil, Psyllium Extract, and Dandelion Extract on Cholesterol Gallstone Dissolution: An In Vitro Comparative Study Against Rowachol®', 'orgStudyIdInfo': {'id': 'AIU-618-11GR-1358'}, 'secondaryIdInfos': [{'id': 'AIU-618-11GR', 'type': 'REGISTRY', 'domain': 'AIU-618-11GR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (G1)', 'description': 'Sesame oil (SO) at 100 mg/mL in dissolving fluid.', 'interventionNames': ['Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (G2)', 'description': 'Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.', 'interventionNames': ['Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (G3)', 'description': '50% Sesame Oil + 50% Extra virgin Olive Oil.', 'interventionNames': ['Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 (G4)', 'description': '50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).', 'interventionNames': ['Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5 (G5)', 'description': ': 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).', 'interventionNames': ['Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6 (G6)', 'description': '50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).', 'interventionNames': ['Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 7 (G7) - Control', 'description': 'Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.', 'interventionNames': ['Drug: Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.']}], 'interventions': [{'name': 'Sesame Oil (SO) at 100 mg/mL in dissolving fluid.', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Sesamum indicum oil (AIU-BC-618-1)'], 'description': 'Pure Sesamum indicum oil (cold-pressed, unrefined) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by homogenization (30 min, 37°C). Used as monotherapy.', 'armGroupLabels': ['Group 1 (G1)']}, {'name': 'Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Olea europaea oil (AIU-BC-618-2)'], 'description': 'Pure Olea europaea oil (first cold-pressed, acidity ≤0.8%) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by vortex mixing (15 min, 25°C). Used as monotherapy.', 'armGroupLabels': ['Group 2 (G2)']}, {'name': '50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['AIU-BC-618-3 (Synergistic Oil Blend)'], 'description': 'A 1:1 (v/v) blend of Sesamum indicum oil (AIU-BC-618-1) and Olea europaea oil (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by mechanical stirring (1 hr, 40°C).', 'armGroupLabels': ['Group 3 (G3)']}, {'name': '50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3'], 'description': '50% Plantago ovata mucilage extract (aqueous extraction, 65°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by sonication (20 min).', 'armGroupLabels': ['Group 4 (G4)']}, {'name': 'Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Taraxacum officinale extract (AIU-BC-618-5) + AIU-BC-618-3'], 'description': '50% Taraxacum officinale root extract (ethanol-water extraction, 70°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by magnetic stirring (30 min, 50°C).', 'armGroupLabels': ['Group 5 (G5)']}, {'name': '50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['AIU-BC-618-6 (Full Synergy Formulation)'], 'description': '25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).', 'armGroupLabels': ['Group 6 (G6)']}, {'name': 'Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.', 'type': 'DRUG', 'otherNames': ['Rowachol® (A. Nattermann & Cie. GmbH, Germany; FDA NDC 12345-678-90; Batch No. ROW-2024-SYR)'], 'description': '25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).', 'armGroupLabels': ['Group 7 (G7) - Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', 'country': 'Syria', 'facility': 'Arab International University', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Duhok', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Mohamad Radwan Sirri', 'investigatorAffiliation': 'University of Duhok'}}}}