Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
1 other identifier
interventional
30
1 country
1
Brief Summary
Hypertension is a progressive cardiovascular syndrome caused by multiple causes, which can lead to changes in the function and structure of the heart and blood vessels. It is the leading risk factor of cardiovascular disease. Berberine (BBR) hydrochloride is an isoquinoline alkaloid (chemical formula: C20H18NO4) extracted from traditional Chinese herb Coptis chinensis. It has been widely used to treat diarrhea and enteritis for hundreds of years in China. BBR has extremely high clinical application value. It is an over-the-counter drug with low price, good safety and few adverse reactions in China. We found that Berberine (BBR) hydrochloride tablets have a hypotensive effect in clinical practice. However, there are few clinical studies on the treatment of hypertensive patients with BBR tablets. In addition, the clinical dosage of BBR tablets is not uniform, and its molecular mechanism is still unclear. In order to further evaluate the clinical efficacy of BBR in reducing blood pressure and improving vascular endothelial injury, we carried out this clinical trial of drug intervention for hypertensive population. After signed the informed consent, the subjects are assigned to the lifestyle intervention group (CON) and berberine hydrochloride group (BBR). The berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) . We will follow up blood pressure and vascular endothelial function in 1 month and 3 months after taking the medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hypertension
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2020
CompletedFirst Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2022
CompletedMarch 10, 2021
March 1, 2021
1.3 years
March 8, 2021
March 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Office blood pressure
BP measurement was in accordance with the method recommended by clinical guidelines. After rest for at least 5 minutes, subjects were examined while seated in a quiet, temperature-controlled room, with the feet on the floor and arm supported at heart level. BP was measured using an automated device at least 2 measurements spaced 2 minutes apart, and additional measurements if the first 2 are quite different. Average BP readings were recorded.
3 months
brachial-ankle pulse wave velocity (baPWV)
baPWV was measured by using an automatic device as reported previously and was expressed as centimeters per second (cm/sec). The measurement of baPWV is generally accepted as the simplest, robust, and reproducible method to represent arterial stiffness.
3 months
Secondary Outcomes (2)
24-hour ambulatory blood pressure monitoring (ABPM)
3 months
brachial arterial flow-mediated dilation (FMD)
3 months
Study Arms (2)
berberine hydrochloride group
EXPERIMENTALthe berberine hydrochloride group (BBR) take berberine hydrochloride tablets
lifestyle intervention group
PLACEBO COMPARATORLifestyle intervention group (CON) refers to healthy lifestyle education
Interventions
the berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months)
The lifestyle intervention group (CON) mainly includes reducing sodium intake, healthy diet guidance, increasing exercise, quitting smoking and restricting alcohol consumption
Eligibility Criteria
You may qualify if:
- Essential hypertension (office blood pressure: systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg
- to 75 years old
- No drugs or dietary supplements that affect blood pressure and vascular endothelial function have been used in the past 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants
- Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of the study, characters of the disease, drug effects, methods of related examinations, and potential risk/benefits of the study
You may not qualify if:
- Individuals with secondary blood pressure rise factors
- Individuals who are hypersensitive or intolerant to the drugs
- Individuals presenting severe constipation
- Individuals with severe heart disease, abnormal liver and kidney function, acute and chronic infections, autoimmune diseases and patients with any history of cancer
- Individuals with mental diseases who are not able to cooperate
- Pregnant women, women during breast-feeding period, or women with expect pregnancy
- Individuals with hemolytic anemia and glucose-6 phosphate dehydrogenase deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jun Taolead
Study Sites (1)
Jun Tao
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Head of the Department of Hypertension and Cardiovascular Disease, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 10, 2021
Study Start
October 22, 2020
Primary Completion
February 22, 2022
Study Completion
May 22, 2022
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share