CompletedPhase 3ACTRN12613000747729

Aged Garlic Extract for heart health: A 3-month randomised placebo-controlled trial

The effect of aged garlic extract on blood pressure and other cardiovascular risk factors in adults with uncontrolled hypertension: A 3-month randomised double-blind placebo-controlled trial

Sponsor

National Institute of Integrative Medicine

Enrollment

100 participants

Start Date

Sep 10, 2013

Study Type

Interventional

Conditions

Hypertension Cardiovascular function

Summary

Our 3-month randomised placebo controlled double-blind trial study aims to investigate the effect of aged garlic extract on blood pressure and other cardiovascular biomarkers including cholesterol, homocysteine and arterial stiffness in a group of adults with uncontrolled hypertension.

Eligibility

Sex: Both males and femalesMin Age: 20 Yearss

Inclusion Criteria4

Essential hypertension: Mean diastolic blood pressure >=90 mm Hg and systolic SBP >=140 mm Hg to be confirmed under trial conditions at the screening appointment (at screening mean DBP of >=88 / SBP >=135 mm Hg will be included)
Either not on blood pressure medication, or on established plan of blood pressure medication (one or more classes) for at least 2 months
The patient’s family doctor /general practitioner (GP) is not planning to change current treatment during the 3 month trial
Able to give informed consent

Exclusion Criteria4

Poor comprehension of written or spoken English
Unstable other medical conditions or serious illness, at the discretion of the GP, e.g. dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis, and pregnancy
Severe hypertension (mean sitting SBP>=180 mm Hg and DBP >=100 mm Hg) at enrolment or subsequent visits during the study. Patients with severe hypertension will be referred back to their GP for further management
Already taking daily garlic supplements

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The active treatment group will be allocated to two capsules of aged garlic extract (AGE, Kyolic, 480 mg, 1.2 mg SAC (2 capsules x 240 mg/0.6 SAC) daily for 3 months. The control group will be allocated to matching placebo capsules. AGE is highly tolerable, and was acceptable for 92% of patients in previous trials. Participants are advised to take AGE in the evening with food to minimise belching. Compliance will be assessed by return of trial capsules, as well as diary entries. Patients will be instructed to mark each day in provided calendars when they have taken the trial and prescription medications, and bring the calendar and the remaining trial medication to their next appointment.