HypertensionPhase 4NCT04790942
Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
A Phase 4 study testing berberine hydrochloride and lifestyle intervention group in people with Hypertension and Endothelial Dysfunction, run by Jun Tao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Endothelial Dysfunction, Blood Pressure
- What is being tested?
- berberine hydrochloride and lifestyle intervention group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2020to 22 May 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension (office blood pressure: systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jun Tao
Guangzhou, Guangdong, 510080
Tao Jun, MD,PhD, +8613922191609, taojungz123@163.com
About this study
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.
Read more
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.
- Conditions
- Hypertension, Endothelial Dysfunction, Blood Pressure
- Being tested
- berberine hydrochloride, lifestyle intervention group
- Keywords
- berberine, hypertension, vascular endothelial function, brachial ankle pulse wave velocity, brachial artery blood flow-mediated vasodilation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
berberine hydrochlorideDrug
Also called BBR
the berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months)
lifestyle intervention groupBehavioural
Also called CON
The lifestyle intervention group (CON) mainly includes reducing sodium intake, healthy diet guidance, increasing exercise, quitting smoking and restricting alcohol consumption
| Study group | Role | What they receive |
|---|---|---|
| berberine hydrochloride group | Experimental | the berberine hydrochloride group (BBR) take berberine hydrochloride tablets Receives: Drug: berberine hydrochloride |
| lifestyle intervention group | Placebo comparator | Lifestyle intervention group (CON) refers to healthy lifestyle education Receives: Behavioral: lifestyle intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
24-hour ambulatory blood pressure monitoring (ABPM)
We record the 24 h ABPM results before recruitment and during the follow-up period.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start22 Oct 2020
- Primary completion22 Feb 2022 (estimated)
- Study completion22 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Tao, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790942
- Sponsor's protocol ID
- BBR-[2020]433
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 10 Mar 2021
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04790942
- Acronym / sponsor ID
- BBR-[2020]433
- Conditions
- Hypertension, Endothelial Dysfunction, Blood Pressure
- Keywords
- berberine, hypertension, vascular endothelial function, brachial ankle pulse wave velocity, brachial artery blood flow-mediated vasodilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jun TaoUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 22 Feb 2022 (estimated)
- Study completion
- 22 May 2022 (estimated)
- First posted
- 10 Mar 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| berberine hydrochloride group | Experimental | Drug: berberine hydrochloridethe berberine hydrochloride group (BBR) take berberine hydrochloride tablets |
| lifestyle intervention group | Placebo comparator | Behavioral: lifestyle intervention groupLifestyle intervention group (CON) refers to healthy lifestyle education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Essential hypertension (office blood pressure: systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg
- 18 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| berberine hydrochlorideAlso: BBRthe berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) | Drug | berberine hydrochloride group |
| lifestyle intervention groupAlso: CONThe lifestyle intervention group (CON) mainly includes reducing sodium intake, healthy diet guidance, increasing exercise, quitting smoking and restricting alcohol consumption | Behavioural | lifestyle intervention group |
Primary outcome
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.
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.
2 secondary outcomes
24-hour ambulatory blood pressure monitoring (ABPM)
Time frame: 3 months
brachial arterial flow-mediated dilation (FMD)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing berberine hydrochloride and lifestyle intervention group in people with Hypertension and Endothelial Dysfunction, run by Jun Tao at 1 site 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Jun, MD, PhD (+8613922191609, taojungz123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office blood pressure (time frame: 3 months). The study lists 2 primary outcomes in all. 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 10 Mar 2021.