Trial Review

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
Sex
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
4/07/2011
Actual
1/08/2011
Date of last participant enrolment
Anticipated
30/03/2012
Actual
28/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
84
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
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
[email protected]
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.