Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®
NCT ID: NCT06972134
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2023-12-15
2024-08-28
Brief Summary
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This 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®.
Methods:
In 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1 (G1)
Sesame oil (SO) at 100 mg/mL in dissolving fluid.
Sesame Oil (SO) at 100 mg/mL in dissolving fluid.
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.
Group 2 (G2)
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
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.
Group 3 (G3)
50% Sesame Oil + 50% Extra virgin Olive Oil.
50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).
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).
Group 4 (G4)
50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).
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).
Group 5 (G5)
: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3
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).
Group 6 (G6)
50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).
50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).
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).
Group 7 (G7) - Control
Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.
Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.
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).
Interventions
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Sesame Oil (SO) at 100 mg/mL in dissolving fluid.
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.
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
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.
50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).
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).
50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).
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).
Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3
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).
50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).
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).
Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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Exclusion Criteria
40 Years
50 Years
ALL
No
Sponsors
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University of Duhok
OTHER
Responsible Party
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Mohamad Radwan Sirri
Clinical Professor
Locations
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Arab International University
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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AIU-618-11GR
Identifier Type: REGISTRY
Identifier Source: secondary_id
AIU-618-11GR-1358
Identifier Type: -
Identifier Source: org_study_id
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