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Burdock and Blood Pressure in African-American Women

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Burdock
Placebo
Sponsored by
Proactive Health Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Active

    Arm Description

    Patients will consume a placebo pill containing methylcellulose.

    Patients will consume 850 mg of burdock twice per day.

    Outcomes

    Primary Outcome Measures

    Blood pressure

    Secondary Outcome Measures

    Body fat percentage
    Extracellular/Total Body Water Ratio
    Hemoglobin A1c
    Blood urea nitrogen
    Creatinine
    Fasting Blood Glucose
    Liver function tests

    Full Information

    First Posted
    July 15, 2015
    Last Updated
    July 29, 2015
    Sponsor
    Proactive Health Labs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02511860
    Brief Title
    Burdock and Blood Pressure in African-American Women
    Official Title
    Burdock and Blood Pressure in African-American Women: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    February 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Proactive Health Labs

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will consume a placebo pill containing methylcellulose.
    Arm Title
    Active
    Arm Type
    Active Comparator
    Arm Description
    Patients will consume 850 mg of burdock twice per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Burdock
    Other Intervention Name(s)
    Arctium lappa
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Intervention Description
    Methylcellulose (inert) tablet taken as placebo
    Primary Outcome Measure Information:
    Title
    Blood pressure
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Body fat percentage
    Time Frame
    6 Weeks
    Title
    Extracellular/Total Body Water Ratio
    Time Frame
    6 Weeks
    Title
    Hemoglobin A1c
    Time Frame
    6 weeks
    Title
    Blood urea nitrogen
    Time Frame
    6 weeks
    Title
    Creatinine
    Time Frame
    6 weeks
    Title
    Fasting Blood Glucose
    Time Frame
    6 weeks
    Title
    Liver function tests
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr De
    Phone
    3108995577
    Ext
    2
    Email
    mde@phlabs.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. De
    Organizational Affiliation
    Proactive Health Labs
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Burdock and Blood Pressure in African-American Women

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