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

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ClinicalTrials.gov Identifier: NCT04790942
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Jun Tao, First Affiliated Hospital, Sun Yat-Sen University

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.


Condition or disease Intervention/treatment Phase
Hypertension Endothelial Dysfunction Blood Pressure Drug: berberine hydrochloride Behavioral: lifestyle intervention group Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : February 22, 2022
Estimated Study Completion Date : May 22, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: CON




Primary Outcome Measures :
  1. Office blood pressure [ Time Frame: 3 months ]
    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.

  2. brachial-ankle pulse wave velocity (baPWV) [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. 24-hour ambulatory blood pressure monitoring (ABPM) [ Time Frame: 3 months ]
    We record the 24 h ABPM results before recruitment and during the follow-up period.

  2. brachial arterial flow-mediated dilation (FMD) [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790942


Contacts
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Contact: Tao Jun, MD, PhD +8613922191609 taojungz123@163.com
Contact: Wang Zhichao, MD +8619868589086 wangzhichao6666@163.com

Locations
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China, Guangdong
Jun Tao Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Tao Jun, MD,PhD    +8613922191609    taojungz123@163.com   
Sponsors and Collaborators
Jun Tao
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Responsible Party: Jun Tao, Director, Head of the Department of Hypertension and Cardiovascular Disease, Principal Investigator, Clinical Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04790942    
Other Study ID Numbers: BBR-[2020]433
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Tao, First Affiliated Hospital, Sun Yat-Sen University:
berberine
hypertension
vascular endothelial function
brachial ankle pulse wave velocity
brachial artery blood flow-mediated vasodilation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases