Clinical trial NCT04790942: Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
Official title: Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Endothelial Dysfunction
Blood Pressure
Keywords: berberine
hypertension
vascular endothelial function
brachial ankle pulse wave velocity
brachial artery blood flow-mediated vasodilation
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Essential hypertension (office blood pressure: systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg
2. 18 to 75 years old
3. 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
4. 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

Exclusion Criteria:

1. Individuals with secondary blood pressure rise factors
2. Individuals who are hypersensitive or intolerant to the drugs
3. Individuals presenting severe constipation
4. Individuals with severe heart disease, abnormal liver and kidney function, acute and chronic infections, autoimmune diseases and patients with any history of cancer
5. Individuals with mental diseases who are not able to cooperate
6. Pregnant women, women during breast-feeding period, or women with expect pregnancy
7. Individuals with hemolytic anemia and glucose-6 phosphate dehydrogenase deficiency

Primary outcomes:
measure: Office blood pressure
timeFrame: 3 months
measure: brachial-ankle pulse wave velocity (baPWV)
timeFrame: 3 months
Secondary outcomes:
measure: 24-hour ambulatory blood pressure monitoring (ABPM)
timeFrame: 3 months
measure: brachial arterial flow-mediated dilation (FMD)
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jun Tao
state: Guangdong
Study officials:
References: