Burdock and Blood Pressure in African-American Women | NCT02511860

Studies
Burdock and Blood Pressure in African-American Women

NCT02511860

Sponsor

Proactive Health Labs

Status

Unknown status

Last Update Posted

Jul 30, 2015Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hypertension

Interventions

Burdock
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Nov 2015Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Jul 15, 2015

First Submission Date that Met QC Criteria

Jul 29, 2015

First Posted Date

Jul 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2015

Last Update Posted Date

Jul 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Burdock	Dietary Supplement	Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Body fat percentage		6 Weeks
Extracellular/Total Body Water Ratio		6 Weeks
Hemoglobin A1c

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr De	Contact	3108995577	2	mde@phlabs.com

Overall Officials

Name	Affiliation	Role
Dr. De	Proactive Health Labs	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000629444	burdock complex

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided