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.
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
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 group | Role | What they receive |
|---|---|---|
| Eucommia | Experimental | Eucommia capsules two orally three times a day for 2 weeks Receives: Dietary Supplement: Eucommia |
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: Eucommia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted29 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2013
- Study completionJan 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank Greenway, M.D., Principal investigator, Pennington Biomedical Research Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of a Standardized Eucommia Extract in the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT00626132
- Acronym / sponsor ID
- PBRC 25036
- Conditions
- Hypertension
- Keywords
- Blood pressure, Herbs, Food
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Feb 2008 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eucommia | Experimental | Dietary Supplement: EucommiaEucommia capsules two orally three times a day for 2 weeks |
| 1 | Placebo comparator | Dietary Supplement: Eucommia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Eucommiatwo capsules three times a day orally for 2 weeks | Dietary supplement | 1, Eucommia |
Primary outcome
Blood pressure and ambulatory monitor
Time frame: After 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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.
Frank Greenway, M.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
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.