Dyslipidemias
Conditions
Keywords
Dyslipidemias, Pueraria lobata, Pueraria thomsonii
Brief summary
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.
Detailed description
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.
Interventions
OTHERPlacebo
The placebo group will take the same dose as the other two groups.
DRUGPueraria lobata
The dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
DRUGPueraria thomsoni
The dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
Sponsors
Jiangxi University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low-density lipoprotein cholesterol | Baseline, month 1, and month 3 | Change from baseline in low-density lipoprotein cholesterol level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride | Baseline, month 1, and month 3 | Change from baseline in triglyceride level |
| Total cholesterol | Baseline, month 1, and month 3 | Change from baseline in total cholesterol level |
| Systolic blood pressure | Baseline, month 1, and month 3 | Changes in systolic blood pressure |
| Diastolic blood pressure | Baseline, month 1, and month 3 | Changes in diastolic blood pressure |
| Fasting blood glucose | Baseline, month 1, and month 3 | Changes in fasting blood glucose |
| Symptoms related to dyslipidemia | Baseline, month 1, and month 3 | Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale |
| High-density lipoprotein cholesterol | Baseline, month 1, and month 3 | Change from baseline in high-density lipoprotein cholesterol level |
| Urine metabolomics | Baseline, month 1, and month 3 | 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 |
| Any adverse events | Baseline, month 1, and month 3 | 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. |
| Any severe adverse events | Baseline, month 1, and month 3 | Severe adverse events refer to events requiring hospitalization, prolonged hospitalization, disability, impact on work capacity, life-threatening or death that occur during clinical trials. |
| Treatment-related adverse events | Baseline, month 1, and month 3 | 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. |
| Withdrawal due to adverse events | Baseline, month 1, and month 3 | Withdrawal due to any adverse events will be counted. |
| Serum metabolomics | Baseline, month 1, and month 3 | 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 |
Countries
China
Outcome results
None listed