NCT00626132

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started May 2007

Longer than P75 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

5.7 years

First QC Date

February 19, 2008

Last Update Submit

December 17, 2015

Conditions

Hypertension

Keywords

Blood pressureHerbsFood

Outcome Measures

Primary Outcomes (1)

  • Blood pressure and ambulatory monitor

    After 2 weeks

Study Arms (2)

Eucommia

EXPERIMENTAL

Eucommia capsules two orally three times a day for 2 weeks

Dietary Supplement: Eucommia

1

PLACEBO COMPARATOR
Dietary Supplement: Eucommia

Interventions

EucommiaDIETARY_SUPPLEMENT

two capsules three times a day orally for 2 weeks

1Eucommia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

EAFP2 peptide, Eucommia ulmoides

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Frank Greenway, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 29, 2008

Study Start

May 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)