Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000151235
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
16/03/2009
Date last updated
8/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and acceptability of aged garlic extract as an adjunct treatment for uncontrolled hypertension: a randomised controlled pilot trial
Scientific title
In individuals with treated but uncontrolled hypertension, how effective and acceptable is aged garlic extract as complementary treatment in reducing blood pressure?
Secondary ID [1] 262326 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
treated uncontrolled hypertension 4318 0
Condition category
Condition code
Cardiovascular 4552 4552 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active group: 4 capsules orally containing 960 mg aged garlic extract (Kyolic) daily for 12 weeks
Intervention code [1] 4048 0
Treatment: Other
Comparator / control treatment
Placebo group: Four capsules orally matching in size, colour and odour the active treatment containing soy protein daily for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5431 0
Blood pressure, mean of three serial measures, with Omron HEM-907 sphyngomanometer by research nurse
Timepoint [1] 5431 0
0.4.8,12 and 16 weeks from baseline and commencement of intervention
Primary outcome [2] 5432 0
Acceptability by questionnaire using 5-point likert scales
Timepoint [2] 5432 0
12 weeks from baseline and commencement of intervention
Secondary outcome [1] 9127 0
estimate of absolute cardiovascular risk reduction, by audit of other cardiovascular risk factors including cholesterol levels, smoking status, family history of premature cardiovascular diseases, age, gender, diabetes
Timepoint [1] 9127 0
baseline

Eligibility
Key inclusion criteria
Blood pressure >140/90 mm Hg, on antihypertensive medication
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
taking regular 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. Consenting patients will be enrolled by the research nurse and assigned to one of two 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2009
Actual
2/03/2009
Date of last participant enrolment
Anticipated
3/03/2010
Actual
26/02/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 4489 0
University
Name [1] 4489 0
Australian Government funded Primary Health Care Research Evaluation Development (PHCRED) Program, The University of Adelaide
Country [1] 4489 0
Australia
Primary sponsor type
Individual
Name
Dr Karin Ried
Address
Frome Rd,
Discipline of General Practice
The University of Adelaide
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 4053 0
Individual
Name [1] 4053 0
Dr Oliver Frank
Address [1] 4053 0
Frome Rd,
Discipline of General Practice
The University of Adelaide
Adelaide, SA 5005
Country [1] 4053 0
Australia
Other collaborator category [1] 563 0
Individual
Name [1] 563 0
Prof Nigel Stocks
Address [1] 563 0
Frome Rd,
Discipline of General Practice
The University of Adelaide
Adelaide, SA 5005
Country [1] 563 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6550 0
Human Research Ethics Committee (HREC) The University of Adelaide
Ethics committee address [1] 6550 0
Ethics committee country [1] 6550 0
Australia
Date submitted for ethics approval [1] 6550 0
Approval date [1] 6550 0
09/10/2008
Ethics approval number [1] 6550 0
H-115-2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29278 0
A/Prof Karin Ried
Address 29278 0
NIIM
21 Burwood Rd
Hawthorn, VIC 3122
Country 29278 0
Australia
Phone 29278 0
+61 3 9912 9545
Fax 29278 0
Email 29278 0
[email protected]
Contact person for public queries
Name 12525 0
Dr Karin Ried
Address 12525 0
Frome Rd,
Discipline of General Practice
The University of Adelaide
Adelaide, SA 5005
Country 12525 0
Australia
Phone 12525 0
+61 8 8303 6281
Fax 12525 0
+61 8 8303 3511
Email 12525 0
[email protected]
Contact person for scientific queries
Name 3453 0
Dr Karin Ried
Address 3453 0
Frome Rd,
Discipline of General Practice
The University of Adelaide
Adelaide, SA 5005
Country 3453 0
Australia
Phone 3453 0
+61 8 8303 6281
Fax 3453 0
+61 8 8303 3511
Email 3453 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.