HypertensionNCT02511860
Burdock and Blood Pressure in African-American Women
A study testing Burdock in people with Hypertension, run by Proactive Health Labs.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Burdock
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to swallow tablets
- African-American race
- Able to travel to our clinic in Santa Monica
Who cannot join
- Severely low blood pressure
- Hypoglycemia
- Baseline creatinine over 1.2
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Burdock, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurdockDietary supplement
Also called Arctium lappa
Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.
PlaceboDietary supplement
Methylcellulose (inert) tablet taken as placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will consume a placebo pill containing methylcellulose. Receives: Dietary Supplement: Placebo |
| Active | Active comparator | Patients will consume 850 mg of burdock twice per day. Receives: Dietary Supplement: Burdock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 6 weeks
Secondary outcomes (7)
Body fat percentage
Measured: 6 Weeks
Extracellular/Total Body Water Ratio
Measured: 6 Weeks
Hemoglobin A1c
Measured: 6 weeks
Blood urea nitrogen
Measured: 6 weeks
Creatinine
Measured: 6 weeks
Fasting Blood Glucose
Measured: 6 weeks
Liver function tests
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proactive Health Labs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. De, Principal investigator, Proactive Health Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511860
- Sponsor's protocol ID
- 00000001
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burdock and Blood Pressure in African-American Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02511860
- Acronym / sponsor ID
- 00000001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Proactive Health LabsUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients will consume a placebo pill containing methylcellulose. |
| Active | Active comparator | Dietary Supplement: BurdockPatients will consume 850 mg of burdock twice per day. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be able to swallow tablets
- African-American race
- Able to travel to our clinic in Santa Monica
Key exclusion criteria (3 listed)
- Severely low blood pressure
- Hypoglycemia
- Baseline creatinine over 1.2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BurdockAlso: Arctium lappaSubjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function. | Dietary supplement | Active |
| PlaceboMethylcellulose (inert) tablet taken as placebo | Dietary supplement | Placebo |
Primary outcome
Blood pressure
Time frame: 6 weeks
7 secondary outcomes
Body fat percentage
Time frame: 6 Weeks
Extracellular/Total Body Water Ratio
Time frame: 6 Weeks
Hemoglobin A1c
Time frame: 6 weeks
Blood urea nitrogen
Time frame: 6 weeks
Creatinine
Time frame: 6 weeks
Fasting Blood Glucose
Time frame: 6 weeks
Liver function tests
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. De principal investigator
Proactive Health Labs
Questions about this trial
What is this clinical trial studying?
A study testing Burdock in people with Hypertension, run by Proactive Health Labs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr De (3108995577 ext. 2, mde@phlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.