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Completed

NCT Number: NCT04861376

Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia

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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanchang Hongdu Hospital of Traditional Chinese Medicine, Nanchang, Jiangxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pueraria lobata

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

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

Other

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

Primary outcomes

  1. Low-density lipoprotein cholesterol

    Time frame: Baseline, month 1, and month 3

    Change from baseline in low-density lipoprotein cholesterol level

Secondary outcomes

  1. High-density lipoprotein cholesterol

    Time frame: Baseline, month 1, and month 3

    Change from baseline in high-density lipoprotein cholesterol level

  2. Triglyceride

    Time frame: Baseline, month 1, and month 3

    Change from baseline in triglyceride level

  3. Total cholesterol

    Time frame: Baseline, month 1, and month 3

    Change from baseline in total cholesterol level

  4. Systolic blood pressure

    Time frame: Baseline, month 1, and month 3

    Changes in systolic blood pressure

  5. Diastolic blood pressure

    Time frame: Baseline, month 1, and month 3

    Changes in diastolic blood pressure

  6. Fasting blood glucose

    Time frame: Baseline, month 1, and month 3

    Changes in fasting blood glucose

  7. Symptoms related to dyslipidemia

    Time frame: Baseline, month 1, and month 3

    Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale

  8. Serum metabolomics

    Time frame: 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

  9. Urine metabolomics

    Time frame: 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

  10. Any adverse events

    Time frame: 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.

  11. Any severe adverse events

    Time frame: 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.

  12. Treatment-related adverse events

    Time frame: 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.

  13. Withdrawal due to adverse events

    Time frame: Baseline, month 1, and month 3

    Withdrawal due to any adverse events will be counted.

Sponsors and collaborators

Lead sponsor

Jiangxi University of Traditional Chinese Medicine

Other

Registry information

Official study title

Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia: A Double-blinded Randomized Placebo-controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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