Cholesterol Gallstone Dissolution
Conditions
Keywords
Gallstone dissolution, Cholesterol gallstones, Natural oils, Herbal extracts, Oleic Acid, Taraxacin, Rowachol®, In vitro study
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSesame 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.
DIETARY_SUPPLEMENTExtra 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.
DIETARY_SUPPLEMENT50% 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).
DIETARY_SUPPLEMENT50% 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).
DIETARY_SUPPLEMENTPlantago 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).
DIETARY_SUPPLEMENT50% 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).
DRUGDrug: 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).
Sponsors
University of Duhok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 50 Years
Healthy volunteers
No
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. \------------------------------------------------------------------------------------------------------------------------------
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gallstone Dissolution Rate | 48-hours, 96-hours, 144 hours | 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: % |
| Cholesterol Release | 48-hours, 96-hours, 144 hours | Total cholesterol released from gallstones into the dissolving medium. Measurement Tool: Cholestech LX-20 autoanalyzer Unit of Measure: mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioactive Compound Concentration | Baseline (T0) | 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 |
| Synergistic Interaction Efficacy | 144 hours (T3) | Comparative analysis of dissolution rates and cholesterol release between combined and individual treatments. Measurement Tool: Ohaus Balance + Cholestech LX-20 Unit of Measure: %, mg |
| Correlation: Compounds vs. Outcomes | 144 hours (T3) | Pearson correlation coefficients between bioactive compound concentrations and dissolution metrics. Measurement Tool: Statistical analysis (SPSS v26) Unit of Measure: r-value (unitless) |
| Predictive Factors of Dissolution | 144 hours (T3) | Multiple regression analysis identifying key predictors (e.g., oleic acid, taraxacin) of efficacy. Measurement Tool: Statistical analysis (SPSS v26) Unit of Measure: β-coefficient |
Countries
Syria
Outcome results
None listed