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

NCT06972134 | Completed

• 2 other identifiers: AIU-618-11GR-1358AIU-618-11GR
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol Gallstone Dissolution

Keywords

Gallstone dissolution; Cholesterol gallstones; Natural oils; Herbal extracts; Oleic Acid; Taraxacin; Rowachol®; In vitro study

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Bioactive Compound Concentration

  Baseline (T0)

• Synergistic Interaction Efficacy

  144 hours (T3)

• Correlation: Compounds vs. Outcomes

  144 hours (T3)

• Predictive Factors of Dissolution

  144 hours (T3)

Study Arms (7)

Group 1 (G1)

EXPERIMENTAL

Sesame oil (SO) at 100 mg/mL in dissolving fluid.

Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.

Group 2 (G2)

EXPERIMENTAL

Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.

Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.

Group 3 (G3)

EXPERIMENTAL

50% Sesame Oil + 50% Extra virgin Olive Oil.

Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).

Group 4 (G4)

EXPERIMENTAL

50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).

Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).

Group 5 (G5)

EXPERIMENTAL

: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).

Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3

Group 6 (G6)

EXPERIMENTAL

50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).

Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).

Group 7 (G7) - Control

ACTIVE COMPARATOR

Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.

Drug: Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.

Interventions

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.

Also known as: Sesamum indicum oil (AIU-BC-618-1)

Group 1 (G1)

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.

Also known as: Olea europaea oil (AIU-BC-618-2)

Group 2 (G2)

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).

Also known as: AIU-BC-618-3 (Synergistic Oil Blend)

Group 3 (G3)

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).

Also known as: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3

Group 4 (G4)

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).

Also known as: Taraxacum officinale extract (AIU-BC-618-5) + AIU-BC-618-3

Group 5 (G5)

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).

Also known as: AIU-BC-618-6 (Full Synergy Formulation)

Group 6 (G6)

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).

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

Group 7 (G7) - Control

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \----------------------------------- 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.
• \------------------------------------------------------------------------------------------------------------------------------

You may not qualify if:

• \----------------------------------- 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.

Sponsors & Collaborators

• University of Duhok: lead

Study Sites (1)

Arab International University

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 37446683 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.

  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.

  PMID: 39391681 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.

  PMID: 35804451 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.

  PMID: 24321208 BACKGROUND

MeSH Terms

Interventions

Sesame Oil; Olive Oil; Psyllium; Rowachol; Terpenes

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Extracts; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 14, 2025
• Study Start: December 15, 2023
• Primary Completion: May 17, 2024
• Study Completion: August 28, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

SY (1)