Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04861376
• Other study ID #: JXUTCM-EBM-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: Jiangxi University of Traditional Chinese Medicine
• Contact: Xu Zhou, M.D.
• Phone: +8618870050733
• Email: zhouxu_ebm[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: December 1, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• 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.
• 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.

Other:
• Placebo
The placebo group will take the same dose as the other two groups.

Locations

Country	Name	City	State
China	Nanchang Hongdu Hospital of Traditional Chinese Medicine	Nanchang	Jiangxi
China	The Affiliated Hospital of Jiangxi University of Chinese Medicine	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density lipoprotein cholesterol	Change from baseline in low-density lipoprotein cholesterol level	Baseline, month 1, and month 3
Secondary	High-density lipoprotein cholesterol	Change from baseline in high-density lipoprotein cholesterol level	Baseline, month 1, and month 3
Secondary	Triglyceride	Change from baseline in triglyceride level	Baseline, month 1, and month 3
Secondary	Total cholesterol	Change from baseline in total cholesterol level	Baseline, month 1, and month 3
Secondary	Systolic blood pressure	Changes in systolic blood pressure	Baseline, month 1, and month 3
Secondary	Diastolic blood pressure	Changes in diastolic blood pressure	Baseline, month 1, and month 3
Secondary	Fasting blood glucose	Changes in fasting blood glucose	Baseline, month 1, and month 3
Secondary	Symptoms related to dyslipidemia	Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale	Baseline, month 1, and month 3
Secondary	Serum metabolomics	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	Baseline, month 1, and month 3
Secondary	Urine metabolomics	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	Baseline, month 1, and month 3
Secondary	Any adverse events	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.	Baseline, month 1, and month 3
Secondary	Any severe adverse events	Severe adverse events refer to events requiring hospitalization, prolonged hospitalization, disability, impact on work capacity, life-threatening or death that occur during clinical trials.	Baseline, month 1, and month 3
Secondary	Treatment-related adverse events	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.	Baseline, month 1, and month 3
Secondary	Withdrawal due to adverse events	Withdrawal due to any adverse events will be counted.	Baseline, month 1, and month 3