Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia

Jiangxi University of Traditional Chinese Medicine

Status: Completed

Conditions: Dyslipidemias

Treatments: Other: Placebo; Drug: Pueraria thomsoni; Drug: Pueraria lobata

Study type: Interventional

Funder types: Other

Identifiers

NCT04861376

JXUTCM-EBM-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 3 patient groups, including a placebo group

Pueraria lobata group

Experimental group

Description:

Pueraria lobata will be made into granules.

Treatment:

Drug: Pueraria lobata

Pueraria thomsoni group

Experimental group

Description:

Pueraria thomsoni will be made into granules.

Treatment:

Drug: Pueraria thomsoni

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo