None listed
Conditions
Brief 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.
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
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.
Sponsors
National Institute of Integrative Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 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 criteria
- 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
Outcome results
None listed