Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia

NCT04861376 | Completed DMC

• 1 other identifier: JXUTCM-EBM-04
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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.

Conditions

Dyslipidemias

Keywords

Dyslipidemias, Pueraria lobata, Pueraria thomsonii

Outcome Measures

Primary Outcomes (1)

• Low-density lipoprotein cholesterol

  Change from baseline in low-density lipoprotein cholesterol level

  Baseline, month 1, and month 3

Secondary Outcomes (13)

• High-density lipoprotein cholesterol

  Baseline, month 1, and month 3

• Triglyceride

  Baseline, month 1, and month 3

• Total cholesterol

  Baseline, month 1, and month 3

• Systolic blood pressure

  Baseline, month 1, and month 3

• Diastolic blood pressure

  Baseline, month 1, and month 3

Study Arms (3)

Pueraria lobata group

EXPERIMENTAL

Pueraria lobata will be made into granules.

Drug: Pueraria lobata

Pueraria thomsoni group

EXPERIMENTAL

Pueraria thomsoni will be made into granules.

Drug: Pueraria thomsoni

Placebo group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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 lobata group

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.

Pueraria thomsoni group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead

Study Sites (2)

Nanchang Hongdu Hospital of Traditional Chinese Medicine

Nanchang, Jiangxi, 330004, China

Location

The Affiliated Hospital of Jiangxi University of Chinese Medicine

Nanchang, Jiangxi, 330004, China

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 27, 2021
• Study Start: June 5, 2021
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)