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®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Cholesterol Release
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •---------------------------------- 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.
- •-----------------------------------------------------------------------------------------------------------------------------
排除标准
- •---------------------------------- 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.
研究组 & 干预措施
Group 1 (G1)
Sesame oil (SO) at 100 mg/mL in dissolving fluid.
干预措施: Sesame Oil (SO) at 100 mg/mL in dissolving fluid. (Dietary Supplement)
Group 2 (G2)
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
干预措施: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid. (Dietary Supplement)
Group 3 (G3)
50% Sesame Oil + 50% Extra virgin Olive Oil.
干预措施: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO). (Dietary Supplement)
Group 4 (G4)
50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
干预措施: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO). (Dietary Supplement)
Group 5 (G5)
: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
干预措施: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3 (Dietary Supplement)
Group 6 (G6)
50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).
干预措施: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO). (Dietary Supplement)
结局指标
主要结局
Cholesterol Release
时间窗: 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
Gallstone Dissolution Rate
时间窗: 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: %
次要结局
- 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))
研究者
Mohamad Radwan Sirri
Clinical Professor
University of Duhok