Standardized Eucommia Extract in the Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Eucommia
Intervention type(s): Dietary Supplement
Intervention description(s): two capsules three times a day orally for 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood pressure; Herbs; Food