Effect of Black Seed Oil on Markers of Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)
研究概览
简要总结
The purpose of this study is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .Also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: adult patients with more than or equal 18 years old.
- •Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
- •Approval to participate and give informed consent.
排除标准
- •Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
- •Uncontrolled hypertension or recent stroke.
- •Chronic kidney disease or chronic liver disease.
- •Intake of black seed oil during the previous two months or any other antioxidant.
研究组 & 干预措施
Group I
this group of patients will receive their standard anti-diabetic treatment in addition to 1800 mg of black seed oil soft gelatin capsule (900 mg twice daily) for three months
干预措施: Anti-Diabetics (Drug)
Group I
this group of patients will receive their standard anti-diabetic treatment in addition to 1800 mg of black seed oil soft gelatin capsule (900 mg twice daily) for three months
干预措施: Black Seed Oil (Dietary Supplement)
Group II
this group of patients will receive their standard anti-diabetic treatment only
干预措施: Anti-Diabetics (Drug)
结局指标
主要结局
Effect on Markers of Endothelial Dysfunction(The change in the level of soluble intercellular adhesion molecule ( ICAM) in serum using ELISA kit)
时间窗: three months
it will be assessed at baseline and after three months of treatment ( to determine the change from baseline at three months ) to determine whether it is effective in reducing marker of endothelial dysfunction (ICAM) in patients with type 2 diabetes mellitus
次要结局
- Effect on Glycemic Control (Measurement of fasting blood glucose )(three months)
- Effect on Glycemic Control (Measurement of glycated hemoglobin)(three months)
- Effect on Lipid Profile ( Measurement of TC,TG, HDL-C,LDL-C)(three months)
- Effect on Inflammatory Status ( Measurement of High sensitive C-Reactive Protein using ELISA kit)(three months)
- Effect on Quality of Life ( Using Diabetes-39 questionnaire )(three months)
研究者
Amany Talaat Abdellatif El-Garf
Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy
Ain Shams University