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Trial registered on ANZCTR


Registration number
ACTRN12612001031853
Ethics application status
Approved
Date submitted
24/09/2012
Date registered
25/09/2012
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute & Short Term effects of specialty mix herb & spice capsules on blood pressure in humans
Scientific title
Acute & short term effects of specialty mix herb & spice capsules on blood pressure in normotensive and hypertensive humans
Secondary ID [1] 281287 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 287429 0
Condition category
Condition code
Cardiovascular 287763 287763 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Culinary Herb and Spice Mixture (Capsule A)

Each capsule contains: 150mg cinnamon, 150 mg clove, 150 mg amla, 150 mg oregano

Dose: 3 capsules per day

Duration: 14 days

Administration: Capsules are taken orally
Intervention code [1] 285703 0
Treatment: Other
Comparator / control treatment
Culinary Herb and Spice Mixture (Capsule B)

Each capsule contains: 150 mg turmeric, 150 mg ginger, 10 mg black pepper, 150 mg chilli

Dose: 3 capsules per day

Duration: 14 days

Administration: Capsules are taken orally
Control group
Active

Outcomes
Primary outcome [1] 287993 0
24 hour Ambulatory blood pressure change from baseline to day 14.
Timepoint [1] 287993 0
Day 14 after baseline
Secondary outcome [1] 299224 0
24 hour Ambulatory blood pressure change from baseline measurement to 24 hours post initial supplementation.
Timepoint [1] 299224 0
24 hours following the initial capsule consumption.

Eligibility
Key inclusion criteria
Age between 18 and 70 years

Weight stable (not lost/gained >4kg in the past month)
Normotensive with Blood pressure at or below 120/80 mmHg
Pre-hypertensive with BP >120/80 but less than 140/90 mmHg
Hypertensive with BP >140/90 but less than 160/100 mmHg
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone on medication for hypertension

Anyone with severe, or stage 2, hypertension which is classified as blood pressure above 160/100mg

Anyone who is pregnant, or intending to become pregnant during the study period

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286016 0
University
Name [1] 286016 0
La Trobe University
Country [1] 286016 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 284864 0
None
Name [1] 284864 0
Address [1] 284864 0
Country [1] 284864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288066 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 288066 0
Ethics committee country [1] 288066 0
Australia
Date submitted for ethics approval [1] 288066 0
Approval date [1] 288066 0
11/09/2012
Ethics approval number [1] 288066 0
1/12/0061

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

Contacts
Principal investigator
Name 34715 0
Dr Catherine Itsiopoulos
Address 34715 0
Department of Dietetics and Human Nutrition La Trobe University Bundoora VIC 3086
Country 34715 0
Australia
Phone 34715 0
+61 3 9479 6032
Fax 34715 0
Email 34715 0
C.Itsiopoulos@latrobe.edu.au
Contact person for public queries
Name 17962 0
Dr Catherine Itsiopoulos
Address 17962 0
Department of Dietetics and Human Nutrition
La Trobe University
Bundoora VIC 3086
Country 17962 0
Australia
Phone 17962 0
+61 3 9479 6032
Fax 17962 0
Email 17962 0
C.Itsiopoulos@latrobe.edu.au
Contact person for scientific queries
Name 8890 0
Dr Markandeya Jois
Address 8890 0
Department of Agricultural Sciences
La Trobe University
Bundoora VIC 3086
Country 8890 0
Australia
Phone 8890 0
+61 3 9479 2172
Fax 8890 0
Email 8890 0
M.Jois@latrobe.edu.au

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.