Clinical trial NCT04861376: Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia
Official title: Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia: A Double-blinded Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Keywords: Dyslipidemias, Pueraria lobata, Pueraria thomsonii
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Low-density lipoprotein cholesterol
timeFrame: Baseline, month 1, and month 3
Secondary outcomes:
measure: High-density lipoprotein cholesterol
timeFrame: Baseline, month 1, and month 3
measure: Triglyceride
timeFrame: Baseline, month 1, and month 3
measure: Total cholesterol
timeFrame: Baseline, month 1, and month 3
measure: Systolic blood pressure
timeFrame: Baseline, month 1, and month 3
measure: Diastolic blood pressure
timeFrame: Baseline, month 1, and month 3
measure: Fasting blood glucose
timeFrame: Baseline, month 1, and month 3
measure: Symptoms related to dyslipidemia
timeFrame: Baseline, month 1, and month 3
measure: Serum metabolomics
timeFrame: Baseline, month 1, and month 3
measure: Urine metabolomics
timeFrame: Baseline, month 1, and month 3
measure: Any adverse events
timeFrame: Baseline, month 1, and month 3
measure: Any severe adverse events
timeFrame: Baseline, month 1, and month 3
measure: Treatment-related adverse events
timeFrame: Baseline, month 1, and month 3
measure: Withdrawal due to adverse events
timeFrame: Baseline, month 1, and month 3
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Nanchang Hongdu Hospital of Traditional Chinese Medicine
state: Jiangxi
city: Nanchang
country: China
facility: The Affiliated Hospital of Jiangxi University of Chinese Medicine
state: Jiangxi
Study officials:
References: