The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000581965
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
6/06/2011
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Aged garlic extract for uncontrolled hypertension: a dose-response trial
Scientific title
Aged garlic extract or placebo for uncontrolled hypertension: a randomised double-blind parallel dose response trial
Secondary ID [1] 262322 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
treated uncontrolled hypertension 268032 0
Condition category
Condition code
Cardiovascular 268161 268161 0 0
Hypertension
Alternative and Complementary Medicine 268164 268164 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active groups: Aged garlic extract (AGE, Kyolic) orally daily for 12 weeks
Group 1: 4 capsules containing 960 mg AGE, 2.4 mg S-AllylCysteine (SAC)
Group 2: 2 capsules containing 480 mg AGE, 1.2 mg SAC
Group 3: 1 capsule containing 240 mg AGE, 0.6 mg SAC
Intervention code [1] 266715 0
Treatment: Other
Comparator / control treatment
Control groups: Placebo capsules orally matched in size, colour, odour to the active treatment containing soy protein daily for 12 weeks

Group 4: 4 placebo capsules
Group 5: 2 placebo capsules
Group 6: 1 placebo capsule
Control group
Placebo

Outcomes
Primary outcome [1] 266904 0
Blood pressure, mean of three serial measures, with Omron HEM-907 sphyngomanometer by research assistant
Timepoint [1] 266904 0
0 (Baseline), 4, 8, 12 weeks since commencement of intervention
Secondary outcome [1] 276597 0
Acceptability by questionnaire using 5-point likert scales
Timepoint [1] 276597 0
12 weeks from baseline and commencement of intervention

Eligibility
Key inclusion criteria
Blood pressure > 140 mm Hg systolic under trial conditions; on established plan of BP medication (one or more classes) for at least 2 months
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent; unstable medical conditions or serious illness; severe hypertension (> 180 mm Hg); already taking daily garlic supplements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hypertensive patients are identified by search of computerised medical practice records and a letter of invitation sent from the patient's general practice. Consenting patients will be screened for eligibility, enrolled if eligible by the research assistant, and assigned to one of 6 groups based on centralised randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a computer generated random number sequence conducted by statistician offsite and not involved in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 267198 0
Hospital
Name [1] 267198 0
Royal Adelaide Hospital New Investigator Clinical Project Grant
Address [1] 267198 0
Discipline of General Practice
178 North Tce, Level 11
Adelaide, SA 5005
Country [1] 267198 0
Australia
Primary sponsor type
Individual
Name
Dr Karin Ried
Address
Discipline of General Practice
178 North Tce, Level 11
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 266268 0
Individual
Name [1] 266268 0
Dr Oliver Frank
Address [1] 266268 0
Discipline of General Practice
178 North Tce, Level 11
Adelaide, SA 5005
Country [1] 266268 0
Australia
Other collaborator category [1] 252042 0
Individual
Name [1] 252042 0
Prof Nigel Stocks
Address [1] 252042 0
Discipline of General Practice
178 North Tce, Level 11
Adelaide, SA 5005
Country [1] 252042 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269190 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 269190 0
115 Grenfell St
The University of Adelaide
Adelaide, SA 5005
Ethics committee country [1] 269190 0
Australia
Date submitted for ethics approval [1] 269190 0
Approval date [1] 269190 0
31/03/2011
Ethics approval number [1] 269190 0
H-026-2011

Summary
Brief summary
The study will investigate the efficacy, dose-reponse relationship and acceptability of aged garlic extract for reducing blood pressure in treated but uncontrolled hypertensive general practice patients.
Trial website
Trial related presentations / publications
Ried K, Frank OR, Stocks N. Aged garlic extract reduces blood pressure in hypertensives: a dose-response trial. Eur J Clin Nutr 2013, 67, 64-70
Public notes

Contacts
Principal investigator
Name 32706 0
Dr Karin Ried
Address 32706 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122

at time of trial (2011-2012):
The University of Adelaide
Discipline of General Practice
Adelaide, SA 5005
Country 32706 0
Australia
Phone 32706 0
+61 423 027 834
Fax 32706 0
Email 32706 0
karinried@niim.com.au
Contact person for public queries
Name 15953 0
Dr Karin Ried
Address 15953 0
Discipline of General Practice
178 North Tce, Level 11
Adelaide, SA 5005
Country 15953 0
Australia
Phone 15953 0
+61-8-8313-6281
Fax 15953 0
+61-8-8313-3511
Email 15953 0
karin.ried@adelaide.edu.au
Contact person for scientific queries
Name 6881 0
Dr Karin Ried
Address 6881 0
Discipline of General Practice
178 North Tce, Level 11
Adelaide, SA 5005
Country 6881 0
Australia
Phone 6881 0
+61-8-8313-6281
Fax 6881 0
+61-8-8313-3511
Email 6881 0
karin.ried@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary