Effects of Hoodia on Blood Pressure and Heart Function
The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of the study is to learn about an herbal product called Hoodia gordonii. We want to know if Hoodia gordonii affects blood pressure, heart rate (pulse), heart pressures, and the heart's electrical conduction system. To participate in this study you must be a healthy volunteer with no known medical problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started May 2008
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMarch 30, 2009
March 1, 2009
2 months
June 5, 2008
March 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals.
Baseline, 1, 3, 5 and 8 hours after taking study drug
Secondary Outcomes (2)
Evaluate other electrocardiographic effects, specifically effects on the QTc, QRS, and Tpe intervals of H. gordonii in healthy individuals.
Baseline, 1, 3, 5, and 8 hours after taking study drug
Evaluate the impact of H. gordonii on the following hemodynamic parameters: Blood Pressure, Cardiac Output, Systemic Vascular Resistance, and Thoracic Fluid Content.
Baseline, 1, 3, 5, and 8 hours after taking study drug.
Study Arms (2)
1
EXPERIMENTALParticipants will take 1- 750 mg capsule of Hoodia gordonii and have the primary and secondary outcomes measured over an 8 hour visit.
2
PLACEBO COMPARATORParticipants will take a placebo capsule and have the primary and secondary outcome measures taken over an 8 hour study day.
Interventions
Eligibility Criteria
You may not qualify if:
- baseline heart rate less than 50 beats/minute or greater than 100 beats/minute
- heart rhythm other than normal sinus
- history of atrial or ventricular arrhythmia
- family history of premature sudden cardiac death
- left ventricular hypertrophy
- atherosclerosis
- hypertension
- palpitations
- T-wave abnormality
- baseline corrected QT(QTc) interval greater than 440 milliseconds (ms)
- thyroid disease
- type 1 or 2 diabetes mellitus
- recurrent headaches
- depression
- any psychiatric condition or neurological disorder
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Nickole N Henyan, PharmD
University of Mississippi Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 9, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
March 30, 2009
Record last verified: 2009-03