Evaluation of the Efficacy of a Nigella Sativa Extract Standardized to 10% Thymoquinone (Nisatol®) in Improving Metabolic and Blood Pressure Parameters and Quality of Life in Perimenopausal Women With Metabolic Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Fasting Blood Glucose
研究概览
简要总结
A prospective, multicenter, randomized controlled study evaluating the efficacy and safety of a Nigella sativa extract standardized to 10% thymoquinone (Nisatol®) in perimenopausal women with metabolic syndrome. The study will assess changes in metabolic and blood pressure parameters, as well as improvements in menopausal symptoms and quality of life.
详细描述
This prospective, multicenter, randomized controlled clinical trial aims to evaluate the efficacy and safety of a food supplement containing Nigella sativa oil standardized to 10% thymoquinone (Nisatol®) in perimenopausal women diagnosed with metabolic syndrome and experiencing climacteric symptoms.
Fifty participants will be randomly assigned to either the intervention group (receiving 2 softgel capsules of Nisatol® daily for 4 months) or a control group following a Mediterranean diet. The primary endpoint is the change from baseline in metabolic and blood pressure parameters, including fasting glucose, lipid profile, cortisolemia, uricemia, and systolic/diastolic blood pressure. The study will also assess quality of life using the Greene Climacteric Scale and monitor treatment safety and tolerability.
The study addresses the need for non-hormonal, evidence-based interventions for managing metabolic and menopausal symptoms in midlife women.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Perimenopausal women aged 40-60 years
- •Presence of climacteric (menopausal) symptoms
- •Diagnosis of metabolic syndrome, defined as alteration of at least 3 of the following:
- •Systolic blood pressure ≥130 mmHg and/or diastolic ≥85 mmHg
- •HDL cholesterol <50 mg/dL
- •Triglycerides ≥150 mg/dL
- •Fasting blood glucose ≥100 mg/dL
- •Uricemia >7 mg/dL
排除标准
- •Use of hormone replacement therapy (HRT)
- •Presence of neoplastic diseases
- •Presence of liver disease, kidney failure, or diabetes mellitus
- •Drug or alcohol abuse
- •Known hypersensitivity to Nigella sativa or any formulation component
结局指标
主要结局
Change in Fasting Blood Glucose
时间窗: Baseline to 4 months
Evaluation of the change in fasting blood glucose from baseline to 4 months.
Change in Total Cholesterol levels, (mg/dL)
时间窗: Baseline to 4 months
Evaluation of total cholesterol from baseline to 4 months.
Change in low-density lipoprotein cholesterol levels, (mg/dL)
时间窗: Baseline to 4 months
Evaluation of low-density lipoprotein cholesterol from baseline to 4 months.
Change in high-density lipoprotein cholesterol levels, (mg/dL)
时间窗: Baseline to 4 months
Evaluation of high-density lipoprotein cholesterol from baseline to 4 months.
Change in Triglycerides levels, (mg/dL)
时间窗: Baseline to 4 months
Evaluation of triglyceride levels from baseline to 4 months.
Change in Blood Pressure
时间窗: Baseline to 4 months
Evaluation of the change in systolic and diastolic blood pressure from baseline to 4 months.
Change in Serum Cortisol levels, (μg/dL)
时间窗: Baseline to 4 months
Evaluation of Cortisol levels from baseline to 4 months.
Change in Serum Uric Acid levels, (mg/dL)
时间窗: Baseline to 4 months
Evaluation of Uric acid levels from baseline to 4 months.
Change in serum Alanine Aminotransferase Enzyme levels, (U/L)
时间窗: Baseline to 4 months
Evaluation of Alanine Aminotransferase Enzyme levels from baseline to 4 months.
Change in serum Aspartate Aminotransferase Enzyme levels, (U/L)
时间窗: Baseline to 4 months
Evaluation of Aspartate Aminotransferase Enzyme levels from baseline to 4 months.
Change in serum Change in Serum Creatinine levels, (mg/dL or µmol/L)
时间窗: Baseline to 4 months
Evaluation of serum creatinine from baseline to 4 months.
Change in serum Creatine Phosphokinase Enzymes levels, (U/L)
时间窗: Baseline to 4 months
Evaluation of Creatine Phosphokinase Enzymes levels from baseline to 4 months.
Change in Climacteric Symptoms
时间窗: Baseline to 4 months
Evaluation using the Greene Climacteric Scale, a 21-item self-reported questionnaire where each item is rated from 0 (not at all) to 3 (extremely), with a total score range from 0 to 63. Higher scores indicate more severe symptoms. Changes will be measured from baseline to 4 months.
次要结局
- Safety and Tolerability(Throughout study duration (4 months))
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences