The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure | NCT00175110

Studies
The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

NCT00175110

Sponsor

Tufts University

Status

Completed

Last Update Posted

Dec 3, 2009Estimated

Enrollment

66Actual

Phase

Phase 1Phase 2

Conditions

Hypertension

Interventions

herbal therapy/botanical therapy (Hibiscus sabdariffa)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2009

Last Update Posted Date

Dec 3, 2009Estimated

Name	Class
Celestial Seasonings	INDUSTRY
Tufts Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Name	Type	Description	Arm Group Labels	Other Names
herbal therapy/botanical therapy (Hibiscus sabdariffa)	Behavioral

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey B Blumberg, Ph.D.	Tufts Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University		Boston	Massachusetts	02111	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20018807	Derived	McKay DL, Chen CY, Saltzman E, Blumberg JB. Hibiscus sabdariffa L. tea (tisane) lowers blood pressure in prehypertensive and mildly hypertensive adults. J Nutr. 2010 Feb;140(2):298-303. doi: 10.3945/jn.109.115097. Epub 2009 Dec 16.

ID	Term
D006973	Hypertension
D058246	Prehypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics