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NCT00175110 Clinical Trial

The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

Hypertension Clinical Trial

Official title:
The Effect of Hibiscus Sabdariffa L. Tisane on Blood Pressure in Prehypertensive and Mildly Hypertensive Men and Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00175110
Other study ID # PV3727
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 12, 2005
Last updated December 2, 2009
Est. completion date December 2007

Study information
Verified date December 2009
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of this study is to find out whether the plant compounds present in Hibiscus sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a beneficial effect on blood pressure in people with mildly elevated blood pressure.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- Systolic blood pressure 120-150 mm Hg

- Diastolic blood pressure 95 mm Hg or less

- Body mass index (BMI) 18.5-34.9 kg/m2

Exclusion Criteria:

- Smoking

- Use of medications that influence blood pressure

- Cardiovascular disease

- Chronic kidney disease

- Diabetes

- Regular use of vitamin C supplements (min 500 mg/day) within prior 30 days

- Regular strenuous aerobic activity greater than 30 min/day

- Excessive intake of caffeine or alcohol

- Pregnancy within last 6 months or during study period

- Abnormal complete blood count (CBC), urinalysis or electrocardiogram (EKG)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• herbal therapy/botanical therapy (Hibiscus sabdariffa)

Locations
Country Name City State
United States Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Tufts University Celestial Seasonings, Tufts Medical Center

Country where clinical trial is conducted

United States, 

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