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Burdock and Blood Pressure in African-American Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02511860
Recruitment Status : Unknown
Verified July 2015 by Proactive Health Labs.
Recruitment status was:  Not yet recruiting
First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Information provided by (Responsible Party):
Proactive Health Labs

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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Burdock Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Burdock and Blood Pressure in African-American Women: A Randomized Controlled Trial
Study Start Date : August 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will consume a placebo pill containing methylcellulose.
Dietary Supplement: Placebo
Methylcellulose (inert) tablet taken as placebo

Active Comparator: Active
Patients will consume 850 mg of burdock twice per day.
Dietary Supplement: Burdock
Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.
Other Name: Arctium lappa

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Body fat percentage [ Time Frame: 6 Weeks ]
  2. Extracellular/Total Body Water Ratio [ Time Frame: 6 Weeks ]
  3. Hemoglobin A1c [ Time Frame: 6 weeks ]
  4. Blood urea nitrogen [ Time Frame: 6 weeks ]
  5. Creatinine [ Time Frame: 6 weeks ]
  6. Fasting Blood Glucose [ Time Frame: 6 weeks ]
  7. Liver function tests [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02511860

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Contact: Dr De 3108995577 ext 2

Sponsors and Collaborators
Proactive Health Labs
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Principal Investigator: Dr. De Proactive Health Labs

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Responsible Party: Proactive Health Labs Identifier: NCT02511860    
Other Study ID Numbers: 00000001
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases