NCT04974853已完成不适用
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation: Feasibility Study on Patients With Mild-to-moderate Hypercholesterolemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Reduction of LDL-cholesterol
研究概览
简要总结
The aim of this feasibility study was to assess the lipid-lowering effects and safety of a Ayurveda formulation containing Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer)
详细描述
The COVID-19 related lockdowns severely affected the healthcare in India, specially in second wave of COVID-19. This research presents the applicability of Ayurveda formulation to analyze the impact on lipid profile during the lockdown.
Patients with hyperlipidemia who referred to Gyansanjeevani were recruited. All participants were enrolled in the study after a complete physical examination and medical history remotely over the virtual secure platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •BMI between 18.5 and 40 kg/m2
- •Total Cholesterol >180 mg/dl
- •No clinically significant medical history
- •Willing to participate to the study by complying with the protocol
- •Able to provide written informed consent
排除标准
- •Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
- •Severe chronic disease
- •History of ischemic cardiovascular event,
- •Uncontrolled hypertension
- •Under treatment or dietary supplement which could affect study parameter
结局指标
主要结局
Reduction of LDL-cholesterol
时间窗: Change from baseline to 2 weeks
次要结局
- Reduction of total cholesterol(Changes from baseline to 2 weeks)
- Reduction of Triglycerides(Change from baseline to 2 weeks)
- Increase of HDL cholesterol(Change from baseline to 2 weeks)
研究者
研究点 (1)
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