Clinical trial NCT06972134: Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®
Official 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol Gallstone Dissolution
Keywords: Gallstone dissolution
Cholesterol gallstones
Natural oils
Herbal extracts
Oleic Acid
Taraxacin
Rowachol®
In vitro study
Lead sponsor: University of Duhok
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gallstone Dissolution Rate
timeFrame: 48-hours, 96-hours, 144 hours
measure: Cholesterol Release
timeFrame: 48-hours, 96-hours, 144 hours
Secondary outcomes:
measure: Bioactive Compound Concentration
timeFrame: Baseline (T0)
measure: Synergistic Interaction Efficacy
timeFrame: 144 hours (T3)
measure: Correlation: Compounds vs. Outcomes
timeFrame: 144 hours (T3)
measure: Predictive Factors of Dissolution
timeFrame: 144 hours (T3)
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Arab International University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.