Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia

NCT ID: NCT04861376

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-05
• Study Completion Date: 2022-01-22

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.

Conditions

Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pueraria lobata group

Pueraria lobata will be made into granules.

Group Type: EXPERIMENTAL

Pueraria lobata

Intervention Type: DRUG

The dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.

Pueraria thomsoni group

Pueraria thomsoni will be made into granules.

Group Type: EXPERIMENTAL

Pueraria thomsoni

Intervention Type: DRUG

The dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo group will take the same dose as the other two groups.

Interventions

Pueraria lobata

The dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.

Intervention Type: DRUG

Pueraria thomsoni

The dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.

Intervention Type: DRUG

Placebo

The placebo group will take the same dose as the other two groups.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xu Zhou

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanchang Hongdu Hospital of Traditional Chinese Medicine

Nanchang, Jiangxi, China

The Affiliated Hospital of Jiangxi University of Chinese Medicine

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

JXUTCM-EBM-04

Identifier Type: -

Identifier Source: org_study_id