Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia: A Double-blinded Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Low-density lipoprotein cholesterol
研究概览
简要总结
Dyslipidemia is an important risk factor for atherosclerotic cardiovascular disease. Maintaining normal levels of lipid indicators can significantly reduce the risk of atherosclerotic cardiovascular disease and mortality. Empirical evidence suggests that adherence to Pueraria lobata and Pueraria thomsonii is useful for improving dyslipidemia, but evidence from randomized controlled trials is lacking. This randomized, double-blind controlled trial is therefore designed to evaluate the efficacy and safety of Pueraria lobata and Pueraria thomsonii for dyslipidemia.
详细描述
Pueraria is an important Chinese herbal medicine. The Pharmacopoeia of the People's Republic of China classifies the Pueraria as Pueraria lobata and Pueraria thomsonii according to the different sources of the plant, both of them is sweet, pungent and cool in nature, and has the effects of relieving fever, quenching thirst, penetrating rashes, raising the Yang to stop diarrhea, activating the meridians and detoxifying alcohol. As early as in the Han Dynasty, Zhongjing Zhang's "Treatise on Febrile Diseases" described the famous formula "Pueraria Tang", which is still an important formula for relieving exterior syndromes.
In clinical practice, the preparations of Pueraria lobata and Pueraria thomsonii are widely used to treat headache, dizziness, hypertension, coronary heart disease, angina pectoris, myocardial infarction and other diseases. For example, the puerarin injection has the effects of dilating blood vessels, slowing down heart rate, reducing myocardial oxygen consumption and improving blood circulation in the heart and brain.
Although the puerarin has been shown to be effective in a variety of cardiovascular diseases, as of now, it is unclear whether Pueraria lobata and Pueraria thomsonii can be used as part of the daily diet to regulate blood lipids and improve dyslipidemia. Therefore, the aim of this study is to conduct a randomized, double-blind controlled trial that includes patients with mildly elevated lipids to evaluate the efficacy and safety of Pueraria lobata and Pueraria thomsonii for dyslipidemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Marginally elevated low-density lipoprotein (LDL-C), 3.4 to 4.1 mmol/L
- •Informed consent to the study and signed the informed consent form
排除标准
- •Patients who have a history of allergy to Pueraria Lobata or Pueraria Thomsonii.
- •Patients who have taken lipid-lowering drugs within a week
- •Patients with secondary dyslipidemia caused by other diseases or medications taken.
- •Pregnant or lactating women.
- •Patients who combine cognitive dysfunction, disorders of consciousness, psychiatric disorders, dyslexia or verbal communication dysfunction
- •Patients with a combination of other serious diseases, such as malignant tumors, hepatic or renal insufficiency, cardiovascular or cerebrovascular disease, etc.
研究组 & 干预措施
Pueraria thomsoni group
Pueraria thomsoni will be made into granules.
干预措施: Pueraria thomsoni (Drug)
Placebo group
The dosage form, specifications and packaging of the placebo will be no different from those of Pueraria lobata and Pueraria thomsoni Granules, and the smell and taste will be basically the same.
干预措施: Placebo (Other)
Pueraria lobata group
Pueraria lobata will be made into granules.
干预措施: Pueraria lobata (Drug)
结局指标
主要结局
Low-density lipoprotein cholesterol
时间窗: Baseline, month 1, and month 3
Change from baseline in low-density lipoprotein cholesterol level
次要结局
- Systolic blood pressure(Baseline, month 1, and month 3)
- Diastolic blood pressure(Baseline, month 1, and month 3)
- Fasting blood glucose(Baseline, month 1, and month 3)
- Symptoms related to dyslipidemia(Baseline, month 1, and month 3)
- Serum metabolomics(Baseline, month 1, and month 3)
- Urine metabolomics(Baseline, month 1, and month 3)
- High-density lipoprotein cholesterol(Baseline, month 1, and month 3)
- Triglyceride(Baseline, month 1, and month 3)
- Total cholesterol(Baseline, month 1, and month 3)
- Any adverse events(Baseline, month 1, and month 3)
- Withdrawal due to adverse events(Baseline, month 1, and month 3)
- Any severe adverse events(Baseline, month 1, and month 3)
- Treatment-related adverse events(Baseline, month 1, and month 3)
研究者
Xu Zhou
Associated professor
Jiangxi University of Traditional Chinese Medicine