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Completed

NCT Number: NCT06972134

Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®

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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Key information

Conditions

Cholesterol Gallstone Dissolution

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arab International University

Damascus, Syria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sesamum indicum oil (AIU-BC-618-1)

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.

Other names: Olea europaea oil (AIU-BC-618-2)

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).

Other names: AIU-BC-618-3 (Synergistic Oil Blend)

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).

Other names: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3

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).

Other names: Taraxacum officinale extract (AIU-BC-618-5) + AIU-BC-618-3

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).

Other names: AIU-BC-618-6 (Full Synergy Formulation)

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).

Other names: Rowachol® (A. Nattermann & Cie. GmbH, Germany; FDA NDC 12345-678-90; Batch No. ROW-2024-SYR)

Primary outcomes

  1. Gallstone Dissolution Rate

    Time frame: 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: %

  2. Cholesterol Release

    Time frame: 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 outcomes

  1. Bioactive Compound Concentration

    Time frame: 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

  2. Synergistic Interaction Efficacy

    Time frame: 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

  3. Correlation: Compounds vs. Outcomes

    Time frame: 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)

  4. Predictive Factors of Dissolution

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Duhok

Other

Registry information

Official study title

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®

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.