Burdock and Blood Pressure in African-American Women

NCT ID: NCT02511860

Last Updated: 2015-07-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-02-29

Brief Summary

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This is a study of women aged 18-65, to determine the physiological effects of consuming burdock root in supplement form. Burdock has long been used by herbalists for its diuretic and blood sugar lowering properties.

Detailed Description

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This study will allow us to determine the effect of burdock consumption on basic laboratory tests such as the complete metabolic panel (CMP) as well as the effect on blood pressure over time. Participants will self-monitor their blood pressures and undergo lab testing. They will also complete symptom inventories to determine subjective factors that change with burdock consumption, such as menstrual water retention. Subjects will undergo electronic body composition testing before and after the intervention.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Patients will consume a placebo pill containing methylcellulose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Methylcellulose (inert) tablet taken as placebo

Active

Patients will consume 850 mg of burdock twice per day.

Group Type ACTIVE_COMPARATOR

Burdock

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.

Interventions

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Burdock

Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Methylcellulose (inert) tablet taken as placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Arctium lappa

Eligibility Criteria

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Inclusion Criteria

* Must be able to swallow tablets
* African-American race
* Able to travel to our clinic in Santa Monica

Exclusion Criteria

* Severely low blood pressure
* Hypoglycemia
* Baseline creatinine over 1.2
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Proactive Health Labs

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. De

Role: PRINCIPAL_INVESTIGATOR

Proactive Health Labs

Central Contacts

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Dr De

Role: CONTACT

3108995577 ext. 2

Other Identifiers

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00000001

Identifier Type: -

Identifier Source: org_study_id

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