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| ID | Type | Description | Link |
|---|---|---|---|
| AIU-618-11GR | Registry Identifier | AIU-618-11GR |
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Objective:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (G1) | Experimental | Sesame oil (SO) at 100 mg/mL in dissolving fluid. |
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| Group 2 (G2) | Experimental | Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid. |
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| Group 3 (G3) | Experimental | 50% Sesame Oil + 50% Extra virgin Olive Oil. |
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| Group 4 (G4) | Experimental | 50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil). |
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| Group 5 (G5) | Experimental | : 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil). |
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| Group 6 (G6) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sesame Oil (SO) at 100 mg/mL in dissolving fluid. | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gallstone Dissolution Rate | Percentage reduction in gallstone weight after treatment. Calculated using the formula: DR%= (W initial-W final)/ W initial×100 Measurement Tool: Ohaus Adventurer Pro AV-2102 balance Unit of Measure: % | 48-hours, 96-hours, 144 hours |
| Cholesterol Release | Total cholesterol released from gallstones into the dissolving medium. Measurement Tool: Cholestech LX-20 autoanalyzer Unit of Measure: mg | 48-hours, 96-hours, 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bioactive Compound Concentration | Quantification of key compounds (oleic acid, taraxacin, arabinoxylan, linoleic acid) in treatment solutions. Measurement Tool: GC-MS (fatty acids), HPLC (plant extracts) Unit of Measure: mg/mL | Baseline (T0) |
| Synergistic Interaction Efficacy |
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Inclusion Criteria:
----------------------------------- 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.
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Exclusion Criteria:
----------------------------------- 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arab International University | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37446683 | Background | 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. | |
| Background | 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. | ||
| 39391681 |
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| Experimental |
50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil). |
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| Group 7 (G7) - Control | Active Comparator | Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid. |
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| Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid. | Dietary Supplement | 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. |
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| 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO). | Dietary Supplement | 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). |
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| 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO). | Dietary Supplement | 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). |
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| Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3 | Dietary Supplement | 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). |
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| 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO). | Dietary Supplement | 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). |
|
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| Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid. | Drug | 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). |
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Comparative analysis of dissolution rates and cholesterol release between combined and individual treatments. Measurement Tool: Ohaus Balance + Cholestech LX-20 Unit of Measure: %, mg |
| 144 hours (T3) |
| Correlation: Compounds vs. Outcomes | Pearson correlation coefficients between bioactive compound concentrations and dissolution metrics. Measurement Tool: Statistical analysis (SPSS v26) Unit of Measure: r-value (unitless) | 144 hours (T3) |
| Predictive Factors of Dissolution | Multiple regression analysis identifying key predictors (e.g., oleic acid, taraxacin) of efficacy. Measurement Tool: Statistical analysis (SPSS v26) Unit of Measure: β-coefficient | 144 hours (T3) |
| Background |
| 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. |
| 35804451 | Background | 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. |
| 24321208 | Background | 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. |
| ID | Term |
|---|---|
| D012715 | Sesame Oil |
| D000069463 | Olive Oil |
| D011620 | Psyllium |
| C018655 | Rowachol |
| D013729 | Terpenes |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D010936 | Plant Extracts |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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