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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
The dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
The dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
The placebo group will take the same dose as the other two groups.
Nanchang Hongdu Hospital of Traditional Chinese Medicine
Nanchang, Jiangxi, China
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Nanchang, Jiangxi, China
Low-density lipoprotein cholesterol
Change from baseline in low-density lipoprotein cholesterol level
Time frame: Baseline, month 1, and month 3
High-density lipoprotein cholesterol
Change from baseline in high-density lipoprotein cholesterol level
Time frame: Baseline, month 1, and month 3
Triglyceride
Change from baseline in triglyceride level
Time frame: Baseline, month 1, and month 3
Total cholesterol
Change from baseline in total cholesterol level
Time frame: Baseline, month 1, and month 3
Systolic blood pressure
Changes in systolic blood pressure
Time frame: Baseline, month 1, and month 3
Diastolic blood pressure
Changes in diastolic blood pressure
Time frame: Baseline, month 1, and month 3
Fasting blood glucose
Changes in fasting blood glucose
Time frame: Baseline, month 1, and month 3
Symptoms related to dyslipidemia
Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale
Time frame: Baseline, month 1, and month 3
Serum metabolomics
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QUADRUPLE
Enrollment
174
To identify changes in in plasma (or serum) endogenous components between patients with dyslipidemia, find biomarkers, and explore the modulation of various biomarkers after taking Pueraria Lobata and Pueraria Thomsonii
Time frame: Baseline, month 1, and month 3
Urine metabolomics
To identify changes in urine endogenous components between patients with dyslipidemia, find biomarkers, and explore the modulation of various biomarkers after taking Pueraria Lobata and Pueraria Thomsonii
Time frame: Baseline, month 1, and month 3
Any adverse events
An adverse event is defined as any medically induced harm, including preventable and nonpreventable adverse events. In this study, adverse events also included those in which blood, urine, stool routine, cardiac, liver and kidney function, and the four coagulation tests exceeded or fell below two times normal values or judged by the physician to be clinically significant abnormal values.
Time frame: Baseline, month 1, and month 3
Any severe adverse events
Severe adverse events refer to events requiring hospitalization, prolonged hospitalization, disability, impact on work capacity, life-threatening or death that occur during clinical trials.
Time frame: Baseline, month 1, and month 3
Treatment-related adverse events
The relationship will be judged based on a combination of the following criteria: 1) there is a logical sequence in time and space between the adverse reaction and the mydriatic intervention; 2) the adverse reaction cannot be explained by other combined treatments or comorbidities; the symptoms of the adverse reaction resolved or disappeared after discontinuation of the intervention; 3) the causal association between the adverse reaction and the intervention is supported by an established pharmacological or phenomenological mechanism; and 4) the reappearance of the adverse event is triggered by reapplication of the drug.
Time frame: Baseline, month 1, and month 3
Withdrawal due to adverse events
Withdrawal due to any adverse events will be counted.
Time frame: Baseline, month 1, and month 3