Burdock and Blood Pressure in African-American Women

Burdock and Blood Pressure in African-American Women: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Burdock

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr De; Phone Number: 2 3108995577; Email: mde@phlabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Arctium lappa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Body fat percentage	6 Weeks
Extracellular/Total Body Water Ratio	6 Weeks
Hemoglobin A1c	6 weeks
Blood urea nitrogen	6 weeks
Creatinine	6 weeks
Fasting Blood Glucose	6 weeks
Liver function tests	6 weeks

Collaborators and Investigators

• Sponsor: Proactive Health Labs
• Investigators: Principal Investigator: Dr. De, Proactive Health Labs

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 00000001