DyslipidemiasNCT04861376
Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia
A study testing Pueraria lobata and Pueraria thomsoni in people with Dyslipidemias, run by Jiangxi University of Traditional Chinese Medicine at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Pueraria lobata and Pueraria thomsoni
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jun 2021to 22 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanchang Hongdu Hospital of Traditional Chinese Medicine
Nanchang, Jiangxi, 330004
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Nanchang, Jiangxi, 330004
About this study
Official title: Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia: A Double-blinded Randomized Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- Pueraria lobata, Pueraria thomsoni, Placebo
- Keywords
- Dyslipidemias, Pueraria lobata, Pueraria thomsonii
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pueraria lobataDrug
The dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
Pueraria thomsoniDrug
The dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
PlaceboOther
The placebo group will take the same dose as the other two groups.
| Study group | Role | What they receive |
|---|---|---|
| Pueraria lobata group | Experimental | Pueraria lobata will be made into granules. Receives: Drug: Pueraria lobata |
| Pueraria thomsoni group | Experimental | Pueraria thomsoni will be made into granules. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-density lipoprotein cholesterol
Change from baseline in low-density lipoprotein cholesterol level
Measured: Baseline, month 1, and month 3
Secondary outcomes (13)
High-density lipoprotein cholesterol
Change from baseline in high-density lipoprotein cholesterol level
Measured: Baseline, month 1, and month 3
Triglyceride
Change from baseline in triglyceride level
Measured: Baseline, month 1, and month 3
Total cholesterol
Change from baseline in total cholesterol level
Measured: Baseline, month 1, and month 3
Systolic blood pressure
Changes in systolic blood pressure
Measured: Baseline, month 1, and month 3
Diastolic blood pressure
Changes in diastolic blood pressure
Measured: Baseline, month 1, and month 3
Fasting blood glucose
Changes in fasting blood glucose
Measured: Baseline, month 1, and month 3
Symptoms related to dyslipidemia
Symptoms related to dyslipidemia that is measured by a Standardized Chinese Medicine Physical Fitness Scale
Measured: Baseline, month 1, and month 3
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
Measured: Baseline, month 1, and month 3
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
Measured: Baseline, month 1, and month 3
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.
Measured: Baseline, month 1, and month 3
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.
Measured: Baseline, month 1, and month 3
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.
Measured: Baseline, month 1, and month 3
Withdrawal due to adverse events
Withdrawal due to any adverse events will be counted.
Measured: Baseline, month 1, and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start5 Jun 2021
- Primary completion22 Jan 2022
- Study completion22 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861376
- Sponsor's protocol ID
- JXUTCM-EBM-04
- Status last verified
- Jul 2024
- First submitted
- 24 Apr 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pueraria Lobata and Pueraria Thomsonii for Mild Dyslipidemia: A Double-blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04861376
- Acronym / sponsor ID
- JXUTCM-EBM-04
- Conditions
- Dyslipidemias
- Keywords
- Dyslipidemias, Pueraria lobata, Pueraria thomsonii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 22 Jan 2022 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pueraria lobata group | Experimental | Drug: Pueraria lobataPueraria lobata will be made into granules. |
| Pueraria thomsoni group | Experimental | Drug: Pueraria thomsoniPueraria thomsoni will be made into granules. |
| Placebo group | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pueraria lobataThe dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug. | Drug | Pueraria lobata group |
| Pueraria thomsoniThe dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug. | Drug | Pueraria thomsoni group |
| PlaceboThe placebo group will take the same dose as the other two groups. | Other | Placebo group |
Primary outcome
Low-density lipoprotein cholesterol
Time frame: Baseline, month 1, and month 3
Change from baseline in low-density lipoprotein cholesterol level
13 secondary outcomes
High-density lipoprotein cholesterol
Time frame: Baseline, month 1, and month 3
Triglyceride
Time frame: Baseline, month 1, and month 3
Total cholesterol
Time frame: Baseline, month 1, and month 3
Systolic blood pressure
Time frame: Baseline, month 1, and month 3
Diastolic blood pressure
Time frame: Baseline, month 1, and month 3
Fasting blood glucose
Time frame: Baseline, month 1, and month 3
Symptoms related to dyslipidemia
Time frame: Baseline, month 1, and month 3
Serum metabolomics
Time frame: Baseline, month 1, and month 3
Urine metabolomics
Time frame: Baseline, month 1, and month 3
Any adverse events
Time frame: Baseline, month 1, and month 3
Any severe adverse events
Time frame: Baseline, month 1, and month 3
Treatment-related adverse events
Time frame: Baseline, month 1, and month 3
Withdrawal due to adverse events
Time frame: Baseline, month 1, and month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pueraria lobata and Pueraria thomsoni in people with Dyslipidemias, run by Jiangxi University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-density lipoprotein cholesterol (time frame: Baseline, month 1, and month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.