Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Blood Pressure; Endothelial Dysfunction
• Intervention / Treatment: Drug: berberine hydrochloride; Behavioral: lifestyle intervention group

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tao Jun, MD, PhD; Phone Number: +8613922191609; Email: taojungz123@163.com
• Study Contact Backup: Name: Wang Zhichao, MD; Phone Number: +8619868589086; Email: wangzhichao6666@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Jun Tao
      • Contact: Tao Jun, MD,PhD; Phone Number: +8613922191609; Email: taojungz123@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: berberine hydrochloride group; the berberine hydrochloride group (BBR) take berberine hydrochloride tablets	Drug: berberine hydrochloride; the berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months); Other Names: BBR
Placebo Comparator: lifestyle intervention group; Lifestyle intervention group (CON) refers to healthy lifestyle education	Behavioral: lifestyle intervention group; The lifestyle intervention group (CON) mainly includes reducing sodium intake, healthy diet guidance, increasing exercise, quitting smoking and restricting alcohol consumption; Other Names: CON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour ambulatory blood pressure monitoring (ABPM)	We record the 24 h ABPM results before recruitment and during the follow-up period.	3 months
brachial arterial flow-mediated dilation (FMD)	Subjects were recommended to rest for 10 min or longer and were examined in a quiet, temperature-controlled room. FMD was examined through noninvasive ultrasound scan; it could dynamically record artery diameter, at rest (baseline) and reactive hyperemia period produced by using the cuff inflated to the greater of 50 mmHg above systolic pressure or 200 mmHg for 5 min as previously described.	3 months

Collaborators and Investigators

• Sponsor: Jun Tao

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Anticipated): February 22, 2022
• Study Completion (Anticipated): May 22, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: hypertension; berberine; vascular endothelial function; brachial ankle pulse wave velocity; brachial artery blood flow-mediated vasodilation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: BBR-[2020]433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No