Effect of Ginseng on Blood Pressure | NCT01913210

Studies
Effect of Ginseng on Blood Pressure

NCT01913210

Sponsor

Unity Health Toronto

Status

Completed

Last Update Posted

Mar 3, 2016Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Blood Pressure

Interventions

Ginseng

Countries

Canada

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

May 2013Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jul 29, 2013

First Submission Date that Met QC Criteria

Jul 29, 2013

First Posted Date

Jul 31, 2013Estimated

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

Mar 2, 2016

Last Update Posted Date

Mar 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

To determine the effect of ginseng on blood pressure control.

Detailed Description

The effect of ginseng on blood pressure control is controversial, originating from an early 1970s observational study, suggesting that ginseng may adversely effect blood pressure. Despite these early findings, extensive research has since suggested that ginseng may have a positive effect on blood pressure. The current study will help clarify present uncertainty on the effect of ginseng on blood pressure control.

This systematic review and meta-analysis will follow The Cochrane Handbook for Systematic Reviews of Interventions. MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Intervention trials that investigate the effect of ginseng on blood pressure in humans will be included.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ginseng	Dietary Supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic Blood Pressure		1 month

Secondary Outcomes

Measure	Description	Time Frame
Diastolic Blood Pressure		1 month
Mean Arterial Pressure		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical trials in humans
randomized treatment allocation
≥ 1 month
suitable control
viable endpoint data

Exclusion Criteria:

non-human studies
non-randomized treatment allocation
< 1 month
lack of a suitable control
no viable endpoint data
trials where ginseng is part of a multi-herbal treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hypertensive Healthy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vladimir Vuksan, PhD	Unity Health Toronto	Principal Investigator
John Sievenpiper, MD, PhD	Unity Health Toronto	Principal Investigator
Allison Komishon, MSc(c)	Unity Health Toronto	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre		Toronto	Ontario	M5C 2T2	Canada

Intervention Browse Module

MeSH Terms

ID	Term
C000713447	Asian ginseng

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided