Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000132347
Ethics application status
Approved
Date submitted
17/06/2007
Date registered
14/03/2008
Date last updated
14/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a herbal preparation containing Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum on circulating adhesion molecules and cardiovascular risk
Scientific title
Effects of a herbal preparation containing Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum on circulating adhesion molecules and cardiovascular risk
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk 2167 0
Condition category
Condition code
Cardiovascular 2262 2262 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese herbal medicine treatment: combination of three Chinese herbs (Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum) in capsule form, oral administration, 1 packet of capsules three times/day for 12 weeks.
Intervention code [1] 2639 0
Prevention
Comparator / control treatment
Matched placebo control in capsule form (polyethylene glycol 6000 [PEG 6000] plus caramel), oral administration, 1 packet of capsules three times/day for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3124 0
Adhesion molecule expression
Timepoint [1] 3124 0
12 weeks
Secondary outcome [1] 5250 0
Cardiovascular risk
Timepoint [1] 5250 0
12 weeks

Eligibility
Key inclusion criteria
Healthy individuals aged 18 years and over with a total plasma cholesterol of 5.0 mmol/L or above, triglyceride level of greater than 2 mmol/L or high density lipoprotein (HDL) cholesterol level of less than 1.0 mmol/L.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included plasma triglyceride levels over 10 mmol/L, established heart disease, other serious medical or psychological conditions, pregnancy, current use of vasoactive medications, warfarin, and postmenopausal hormone therapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study medications coded and labelled numerically. Computerised random number code generated, boxes of study medications labelled accordingly. Patients allocated study medications in numberical sequence in order of enrolment into study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 609 0
3000

Funding & Sponsors
Funding source category [1] 3161 0
Commercial sector/Industry
Name [1] 3161 0
Tianjin Tasly Pharmaceutical Co Ltd
Country [1] 3161 0
China
Funding source category [2] 3162 0
Government body
Name [2] 3162 0
Australia-China Fund Grant
Country [2] 3162 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Alfred Lane
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 2196 0
None
Name [1] 2196 0
Nil
Address [1] 2196 0
Country [1] 2196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5138 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 5138 0
Ethics committee country [1] 5138 0
Australia
Date submitted for ethics approval [1] 5138 0
Approval date [1] 5138 0
06/01/2003
Ethics approval number [1] 5138 0
Ethics committee name [2] 5139 0
Monash University Ethics Committee
Ethics committee address [2] 5139 0
Ethics committee country [2] 5139 0
Australia
Date submitted for ethics approval [2] 5139 0
Approval date [2] 5139 0
16/09/2003
Ethics approval number [2] 5139 0

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

Contacts
Principal investigator
Name 27649 0
Address 27649 0
Country 27649 0
Phone 27649 0
Fax 27649 0
Email 27649 0
Contact person for public queries
Name 11024 0
Professor Paul Komesaroff
Address 11024 0
Monash University
Department of Medicine
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 11024 0
Australia
Phone 11024 0
+61 3 99030622
Fax 11024 0
Email 11024 0
paul.komesaroff@med.monash.edu.au
Contact person for scientific queries
Name 1952 0
Professor Paul Komesaroff
Address 1952 0
Monash University
Department of Medicine
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 1952 0
Australia
Phone 1952 0
+61 3 99030622
Fax 1952 0
Email 1952 0
paul.komesaroff@med.monash.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.