Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia
Primary Purpose
Dyslipidemias
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pueraria lobata
Pueraria thomsoni
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring Dyslipidemias, Pueraria lobata, Pueraria thomsonii
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.
Sites / Locations
- Nanchang Hongdu Hospital of Traditional Chinese Medicine
- The Affiliated Hospital of Jiangxi University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Pueraria lobata group
Pueraria thomsoni group
Placebo group
Arm Description
Pueraria lobata will be made into granules.
Pueraria thomsoni will be made into granules.
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.
Outcomes
Primary Outcome Measures
Low-density lipoprotein cholesterol
Change from baseline in low-density lipoprotein cholesterol level
Secondary Outcome Measures
High-density lipoprotein cholesterol
Change from baseline in high-density lipoprotein cholesterol level
Triglyceride
Change from baseline in triglyceride level
Total cholesterol
Change from baseline in total cholesterol level
Systolic blood pressure
Changes in systolic blood pressure
Diastolic blood pressure
Changes in diastolic blood pressure
Fasting blood glucose
Changes in fasting blood glucose
Symptoms related to dyslipidemia
Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale
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
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
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.
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.
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.
Withdrawal due to adverse events
Withdrawal due to any adverse events will be counted.
Full Information
NCT ID
NCT04861376
First Posted
April 24, 2021
Last Updated
April 24, 2021
Sponsor
Jiangxi University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04861376
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2021 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangxi University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
Dyslipidemias, Pueraria lobata, Pueraria thomsonii
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pueraria lobata group
Arm Type
Experimental
Arm Description
Pueraria lobata will be made into granules.
Arm Title
Pueraria thomsoni group
Arm Type
Experimental
Arm Description
Pueraria thomsoni will be made into granules.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pueraria lobata
Intervention Description
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
Intervention Name(s)
Pueraria thomsoni
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo group will take the same dose as the other two groups.
Primary Outcome Measure Information:
Title
Low-density lipoprotein cholesterol
Description
Change from baseline in low-density lipoprotein cholesterol level
Time Frame
Baseline, month 1, and month 3
Secondary Outcome Measure Information:
Title
High-density lipoprotein cholesterol
Description
Change from baseline in high-density lipoprotein cholesterol level
Time Frame
Baseline, month 1, and month 3
Title
Triglyceride
Description
Change from baseline in triglyceride level
Time Frame
Baseline, month 1, and month 3
Title
Total cholesterol
Description
Change from baseline in total cholesterol level
Time Frame
Baseline, month 1, and month 3
Title
Systolic blood pressure
Description
Changes in systolic blood pressure
Time Frame
Baseline, month 1, and month 3
Title
Diastolic blood pressure
Description
Changes in diastolic blood pressure
Time Frame
Baseline, month 1, and month 3
Title
Fasting blood glucose
Description
Changes in fasting blood glucose
Time Frame
Baseline, month 1, and month 3
Title
Symptoms related to dyslipidemia
Description
Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale
Time Frame
Baseline, month 1, and month 3
Title
Serum metabolomics
Description
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
Time Frame
Baseline, month 1, and month 3
Title
Urine metabolomics
Description
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
Time Frame
Baseline, month 1, and month 3
Title
Any adverse events
Description
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.
Time Frame
Baseline, month 1, and month 3
Title
Any severe adverse events
Description
Severe adverse events refer to events requiring hospitalization, prolonged hospitalization, disability, impact on work capacity, life-threatening or death that occur during clinical trials.
Time Frame
Baseline, month 1, and month 3
Title
Treatment-related adverse events
Description
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.
Time Frame
Baseline, month 1, and month 3
Title
Withdrawal due to adverse events
Description
Withdrawal due to any adverse events will be counted.
Time Frame
Baseline, month 1, and month 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Zhou, M.D.
Phone
+8618870050733
Email
zhouxu_ebm@hotmail.com
Facility Information:
Facility Name
Nanchang Hongdu Hospital of Traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Facility Name
The Affiliated Hospital of Jiangxi University of Chinese Medicine
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Yu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia
We'll reach out to this number within 24 hrs