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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
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.
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.
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% 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).
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).
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).
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).
Arab International University
Damascus, Syria
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: %
Time frame: 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
Time frame: 48-hours, 96-hours, 144 hours
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
Time frame: Baseline (T0)
Synergistic Interaction Efficacy
Comparative analysis of dissolution rates and cholesterol release between combined and individual treatments. Measurement Tool: Ohaus Balance + Cholestech LX-20 Unit of Measure: %, mg
Time frame: 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)
Time frame: 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
Time frame: 144 hours (T3)
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