Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract
NCT ID: NCT01331486
Last Updated: 2013-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-05-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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Placebo
Placebo capsule
Placebo capsule
Matched placebo liquid capsule
Low dose
Hawthorn
Hawthorn standardized extract liquid capsule
Mid dose
Hawthorn
Hawthorn standardized extract liquid capsule
High dose
Hawthorn
Hawthorn standardized extract liquid capsule
Interventions
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Hawthorn
Hawthorn standardized extract liquid capsule
Placebo capsule
Matched placebo liquid capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 years and older.
3. Ability to speak English
Exclusion Criteria
2. Current tobacco use.
3. Diagnosed with diabetes, known coronary artery disease, severe aortic stenosis, idiopathic hypertrophic subaortic stenosis (IHSS), or upper extremity vascular obstruction.
4. Pregnancy or breast feeding.
5. Using estrogen-containing birth control methods.
6. Unwillingness to forgo vitamins C and E, fish oil, niacin, arginine, OTC decongestants, and NSAIDs such as advil, motrin, and nuprin during the study period.
7. Unwillingness to forgo use of phosphodiesterase inhibitors (sildenafil - 36 hours, vardenafil - 36 hours, tadalafil - 96 hours) prior to study visits.
8. Unwillingness to refrain from vigorous exercise on the morning of study visits.
9. Women with childbearing potential who do not agree to practice effective birth control (condom, diaphragm, cervical cap, copper IUD, abstinence).
18 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Gary N Asher, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UNC
Locations
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UNC Department of Family Medicine
Chapel Hill, North Carolina, United States
Countries
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References
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Asher GN, Viera AJ, Weaver MA, Dominik R, Caughey M, Hinderliter AL. Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial. BMC Complement Altern Med. 2012 Mar 29;12:26. doi: 10.1186/1472-6882-12-26.
Other Identifiers
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09-2279
Identifier Type: -
Identifier Source: org_study_id
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