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

Not Applicable

Completed

• Conditions: Cholesterol Gallstone Dissolution
• Interventions: Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.; Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.; Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).; Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).; Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3; Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).

• Registration Number: NCT06972134
• Lead Sponsor: University of Duhok

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Primary Completion: 2024-05-17
• Study Completion: 2024-08-28
• Study First Submitted: 2025-04-28
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (G1)	Sesame Oil (SO) at 100 mg/mL in dissolving fluid.	Sesame oil (SO) at 100 mg/mL in dissolving fluid.
Group 2 (G2)	Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.	Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
Group 3 (G3)	50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).	50% Sesame Oil + 50% Extra virgin Olive Oil.
Group 4 (G4)	50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).	50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
Group 5 (G5)	Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3	: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
Group 6 (G6)	50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).	50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Arab International University; 🇸🇾 Damascus, Syrian Arab Republic