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HypertensionPhase 2NCT00626132

Standardized Eucommia Extract in the Treatment of Hypertension

A Phase 2 study testing Eucommia in people with Hypertension, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate that eucommia, an herb used in China for making tea, is safe and effective for lowering blood pressure in humans with high blood pressure. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Eucommia
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
May 2007to Jan 2013
Phase
Phase 2
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Eligible criteria:

  • Are a healthy male or female
  • Are 18 to 70 years of age
  • Have a BMI (a number calculated from your height and weight) less than 40
  • Have an average blood pressure measure between 120-160/80-100

Ineligible criteria:

  • Smoke or have smoked in the past 6 months
  • Have diabetes mellitus
  • Have heart disease including left ventricular hypertrophy, prior myocardial infarction (heart attack), angina pectoris (heart pain), a prior revascularization procedure (heart bypass), heart failure or stroke
  • Have nephropathy (kidney disease)
  • Have peripheral arterial disease (blockage of the arteries to your body)
  • Have retinopathy (disease of the back of the eye)
  • Take a beta-adrenergic blocking drug
  • Regularly use medications that would influence weight, or unstable doses of medicines that would affect blood pressure
  • Are pregnant or nursing a baby
  • Are taking blood pressure medications and not on a stable dose for 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Evaluation of the Safety and Efficacy of a Standardized Eucommia Extract in the Treatment of Hypertension

The purpose of this study is to demonstrate that eucommia, an herb used in China for making tea, is safe and effective for lowering blood pressure in humans with high blood pressure.

Read the detailed description

Eucommia is an herb used as a tea in China and by traditional Chinese doctors to treat high blood pressure. People with high blood pressure in Russia were given eucommia with a reduction in blood pressure and without side effects. LSU Board of Regents supported this research to develop an herbal product that will maintain a healthy blood pressure. Dr. Liu with the LSU Ag Center extracted and standardized the eucommia. Dr. Baker with the LSU Vet School conducted safety studies in rats finding that eucommia was without side effects at 7 times the doses to be used in this study and there was a reduction in blood pressure in the rats. Dr. Greenway demonstrated that eucommia extract is a beta-adrenergic blocker, a mechanism used in approved blood pressure medications like propanolol.

Thirty healthy subjects will participate in this study who are between 18 and 70 years of age with less than 2 cardiovascular risk factors, and an average blood pressure of 120-160/80-100 on 3 screening visits to the Pennington Center clinic each a week apart. This level of high blood pressure can be safely treated with diet and lifestyle change alone for a 6 to 12-month period.

During screening subjects will come to the Pennington Center clinic on 3 occasions and have a medical history, physical examination, blood tests, and electrocardiogram (heart tracing) on 1 of these 3 visits, and 24-hour blood pressure monitoring. Visits will last approximately 30 minutes to 1 hour. If the subject is of childbearing potential, a pregnancy test will be done. A small box will be given to subjects that will be attached to a blood pressure cuff to carry on an arm for 24 hours on one occasion. This device will automatically take blood pressure every half hour during the 24-hour period.

Qualifying subjects return to the Pennington Center clinic on 3 occasions and will be asked to take 2 capsules 3 times a day for 2 weeks. The capsules could contain 1 gram of eucommia extract or a placebo (inactive sugar pill). Subjects have a 50:50 chance of receiving the eucommia and the assignment to eucommia or placebo will be made by chance (like flipping a coin). On each visit subjects will return the pill bottle, be given new medication to last until the next visit, be asked about any side effects, and have blood pressure taken. They will also be questioned about any adverse events. If blood pressure exceeds 180/110 on these visits, the subjects will be withdrawn from the trial and referred to their physician. At the end of the study, the blood tests, electrocardiogram, 24-hour blood pressure monitor, and physical examination will be repeated. These visits will last approximately 30 minutes to 1 hour, with the exception of visit 4 which will last approximately 1½ hours. The entire study will last approximately 5 weeks.

The effectiveness of eucommia in reducing blood pressure will be assessed by comparing the blood pressure readings from clinic visits and the 24-hour blood pressure monitoring. The safety of eucommia will be assessed from the blood tests, side effects, urinalysis, electrocardiogram, and physical examination. Subjects will be paid $35 per non-screening visit and an extra $30 for completing the study for a total of $100. At the end of the study or at the time of early termination, subjects will be instructed in the diet and lifestyle changes recommended by the National Institutes of Health and referred to their physicians.

There have been no side effects reported from taking eucommia and there was no toxicity in rats given the equivalent of 7 times the dose to be used in this trial. Drawing blood from an arm vein can cause discomfort from the needle, bruising, and rarely fainting or infection. These risks will be minimized by trained technicians and sterile technique. The 24-hour blood pressure monitor may be annoying and interrupt sleep when it automatically takes blood pressure.

Conditions
Hypertension
Being tested
Eucommia
Keywords
Blood pressure, Herbs, Food
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EucommiaDietary supplement

    two capsules three times a day orally for 2 weeks

Study groups in NCT00626132
Study groupRoleWhat they receive
EucommiaExperimentalEucommia capsules two orally three times a day for 2 weeks
Receives: Dietary Supplement: Eucommia
1Placebo comparatorNot described
Receives: Dietary Supplement: Eucommia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure and ambulatory monitor

    Measured: After 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00626132
Sponsor's protocol ID
PBRC 25036
Status last verified
Dec 2015
First submitted
19 Feb 2008
Last updated
18 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eucommia in people with Hypertension, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 18 Dec 2015. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure and ambulatory monitor (time frame: After 2 weeks). 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 18 Dec 2015.

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