Burdock and Blood Pressure in African-American Women

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02511860
• Other study ID #: 00000001
• Status: Not yet recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: July 29, 2015
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Proactive Health Labs
• Contact: Dr De
• Phone: 3108995577
• Email: mde[@]phlabs.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Burdock
Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.
• Placebo
Methylcellulose (inert) tablet taken as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Proactive Health Labs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		6 weeks	No
Secondary	Body fat percentage		6 Weeks	No
Secondary	Extracellular/Total Body Water Ratio		6 Weeks	No
Secondary	Hemoglobin A1c		6 weeks	No
Secondary	Blood urea nitrogen		6 weeks	No
Secondary	Creatinine		6 weeks	No
Secondary	Fasting Blood Glucose		6 weeks	No
Secondary	Liver function tests		6 weeks	No