A Randomized, Controlled, Multicentre, Three-Arm Clinical Trial to Evaluate the Efficacy and Safety of Berberol® P Compared With Berberol® K in Adults With Mild-to-Moderate Hypercholesterolaemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 255
- 试验地点
- 4
- 主要终点
- Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline
研究概览
简要总结
This randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia.
A total of 255 participants will be randomized in a 1:1:1 ratio to receive Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily for 12 weeks. The study will primarily assess whether Berberol® P is non-inferior to Berberol® K in reducing low-density lipoprotein cholesterol (LDL-C). Changes in other lipid parameters, glucose metabolism, anthropometric measures, blood pressure, and safety will also be evaluated.
详细描述
Hypercholesterolaemia is an important modifiable cardiovascular risk factor. Nutraceutical approaches may provide an option for individuals with mild-to-moderate hypercholesterolaemia, particularly when lifestyle measures alone are insufficient.
This is a randomized, controlled, multicentre, three-arm clinical trial evaluating two daily doses of Berberol® P compared with Berberol® K. Eligible participants will be randomized in a 1:1:1 ratio to one of three treatment groups: Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily. Treatment will continue for 12 weeks.
The primary objective is to evaluate the non-inferiority of Berberol® P compared with Berberol® K with respect to the change in LDL-C after 12 weeks of treatment. The study will also evaluate effects on the lipid profile, glucose metabolism, anthropometric parameters and blood pressure, as well as the safety and tolerability of the interventions.
A total of 255 participants are planned to be enrolled across multiple study centres.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Male or female
- •LDL-C 115-190 mg/dL and/or total cholesterol 200-260 mg/dL
- •Triglycerides <400 mg/dL
- •Willingness to maintain stable diet and physical activity
- •Written informed consent for study participation obtained prior to the start of the study
排除标准
- •Use of statins, ezetimibe, fibrates, PCSK9 inhibitors, or lipid-lowering nutraceuticals within 30 days prior to enrollment
- •Uncontrolled diabetes
- •Significant liver or kidney disease
- •Pregnancy or breastfeeding
- •Known intolerance to any component of the study products
- •Recent cardiovascular events
- •Alcohol or drug abuse
- •Participation in another clinical trial within 30 days prior to enrollment
- •Lack of written informed consent
结局指标
主要结局
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline
时间窗: Baseline to Week 12
Change in serum LDL-C concentration from baseline to the end of treatment. The primary analysis will assess the non-inferiority of Berberol® P compared with Berberol® K in reducing LDL-C.
次要结局
- Change in Total Cholesterol From Baseline(Baseline to Week 12)
- Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline(Baseline to Week 12)
- Change in Triglycerides From Baseline(Baseline to Week 12)
- Change in Fasting Blood Glucose From Baseline(Baseline to Week 12)
- Change in Glycated Hemoglobin (HbA1c) From Baseline(Baseline to Week 12)
- Change in Fasting Insulin From Baseline(Baseline to Week 12)
- Change in Systolic Blood Pressure From Baseline(Baseline to Week 12)
- Change in Diastolic Blood Pressure From Baseline(Baseline to Week 12)
- Change in Heart Rate From Baseline(Baseline to Week 12)
- Incidence of Adverse Events(Baseline to Week 12)
- Change in Safety Laboratory Parameters From Baseline(Baseline to Week 12)
- Change in Body Weight From Baseline(Baseline to Week 12)
- Change in Waist Circumference From Baseline(Baseline to Week 12)
- Change in Non-HDL Cholesterol From Baseline(Baseline to Week 12)
- Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline(Baseline to Week 12)
- Change in Total Cholesterol to HDL Cholesterol Ratio (TC/HDL) From Baseline(Baseline to Week 12)
- Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL/HDL) From Baseline(Baseline to Week 12)
- Change in Triglyceride to HDL Cholesterol Ratio (TG/HDL) From Baseline(Baseline to Week 12)
- Change in Remnant Cholesterol From Baseline(Baseline to Week 12)
- Change in Apolipoprotein A1 (Apo A1) From Baseline(Baseline to Week 12)
- Change in Apolipoprotein B (ApoB) From Baseline(Baseline to Week 12)
- Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB/Apo A1) From Baseline(Baseline to Week 12)
- Severity of Undesirable Symptoms(Baseline to Week 12)
- Frequency of Undesirable Symptoms(Baseline to Week 12)
- Participant-Reported Treatment Tolerability Score on a 0-10 Scale(Week 12)
- Participant-Reported Treatment Adherence Percentage(Week 12)
- Treatment Adherence Based on Returned Unused Tablets(Week 12)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences