Arterial Stiffness, Blood Pressure Clinical Trial
— KRABOfficial title:
Acute Effect of Rg3-enriched Korean Red Ginseng (Steamed Panax Ginseng C.A. Meyer) Standardized Extract on Arterial Stiffness and Aortic and Brachial Blood Pressure in Healthy Individuals
| NCT number | NCT01951443 |
| Other study ID # | KRAB |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | August 21, 2013 |
| Last updated | April 25, 2014 |
| Start date | August 2013 |
| Verified date | March 2014 |
| Source | St. Michael's Hospital, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Healthy - Age 18-70 years - BMI < 30 kg/m2 - Brachial systolic blood pressure < 140 mmHg - Brachial diastolic blood pressure < 90 mmHg Main Exclusion Criteria: - BMI >30kg/m2 - Hypertensive (brachial systolic BP =140mmHg and/or diastolic BP =90mmHg) - Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| St. Michael's Hospital, Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | To evaluate the acute safety of Rg3-KRG in healthy adult volunteers using a 48hr symptoms questionnaire. | Two weeks | Yes | |
| Primary | To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx). | Two weeks (measurements taken on two separate visits with minimum one week washout) | No | |
| Secondary | To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers. | Two weeks (measurements taken on two separate visits with minimum one week washout) | No |