NCT02511860

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 15, 2015

Last Update Submit

July 29, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    6 weeks

Secondary Outcomes (7)

  • Body fat percentage

    6 Weeks

  • Extracellular/Total Body Water Ratio

    6 Weeks

  • Hemoglobin A1c

    6 weeks

  • Blood urea nitrogen

    6 weeks

  • Creatinine

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will consume a placebo pill containing methylcellulose.

Dietary Supplement: Placebo

Active

ACTIVE COMPARATOR

Patients will consume 850 mg of burdock twice per day.

Dietary Supplement: Burdock

Interventions

BurdockDIETARY_SUPPLEMENT

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

Also known as: Arctium lappa
Active
PlaceboDIETARY_SUPPLEMENT

Methylcellulose (inert) tablet taken as placebo

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severely low blood pressure
  • Hypoglycemia
  • Baseline creatinine over 1.2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

burdock complex

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Dr. De

    Proactive Health Labs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr De

CONTACT

3108995577mde@phlabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 30, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

July 30, 2015

Record last verified: 2015-07