Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000133336
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 Chinese herbal preparation containing Radix Polygoni Multiflori and Radix Salviae Miltiorrhizae on cardiovascular disease risk
Scientific title
Effects of a Chinese herbal preparation containing Radix Polygoni Multiflori and Radix Salviae Miltiorrhizae on cardiovascular disease risk
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk 2166 0
Condition category
Condition code
Cardiovascular 2261 2261 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment with a Chinese medicine herbal preparation, the He Shou Wu Capsule (containing four Chinese herbs) in capsule form, 1 packet of capsules three times/day (oral administration) for 12 weeks.
Intervention code [1] 2640 0
Treatment: Other
Comparator / control treatment
Matched placebo (polyethylene glycol 6000 [PEG 6000] plus caramel) in capsule form. Oral administration. One packet of capsules three times/day for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3123 0
Calculated cardiovascular risk using PROCAM algorithm
Timepoint [1] 3123 0
12 weeks
Secondary outcome [1] 5249 0
Adhesion molecule expression
Timepoint [1] 5249 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
No limit
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 labelled sequentially and numerically. Computerised random number generated code used to determine study medication assignment (i.e herbal medicine or placebo). Study medications allocated to participants 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
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] 596 0
3004
Recruitment postcode(s) [2] 610 0
3181

Funding & Sponsors
Funding source category [1] 2423 0
Government body
Name [1] 2423 0
Australia-China Fund
Country [1] 2423 0
Australia
Funding source category [2] 3163 0
Commercial sector/Industry
Name [2] 3163 0
Tianjin Tasly Pharmaceutical Co Ltd
Country [2] 3163 0
China
Primary sponsor type
University
Name
Monash University
Address
Monash Medical School
Alfred Lane
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 2195 0
None
Name [1] 2195 0
Nil
Address [1] 2195 0
Country [1] 2195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4277 0
Monash University Ethics Committee
Ethics committee address [1] 4277 0
Department of Medicine
Monash University
Clayton Campus
Clayton VIC 3168
Ethics committee country [1] 4277 0
Australia
Date submitted for ethics approval [1] 4277 0
Approval date [1] 4277 0
16/09/2003
Ethics approval number [1] 4277 0
Ethics committee name [2] 5140 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 5140 0
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Ethics committee country [2] 5140 0
Date submitted for ethics approval [2] 5140 0
Approval date [2] 5140 0
06/01/2003
Ethics approval number [2] 5140 0

Summary
Brief summary
This parallel double-blinded and randomised placebo controlled study examined effects of He Shou Wu Capsule (HSWC), a pharmaceutical preparation derived principally from the Chinese herbs Radix Polygoni Multiflori, Radix Salviae Miltiorrhizae, on a range of cardiovascular disease risk factors in subjects with mild to moderate hypercholesterolemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27648 0
Address 27648 0
Country 27648 0
Phone 27648 0
Fax 27648 0
Email 27648 0
Contact person for public queries
Name 11023 0
Professor Paul Komesaroff
Address 11023 0
Monash University
Department of Medicine
Alfred Hospital
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 11023 0
Australia
Phone 11023 0
+61 3 99030622
Fax 11023 0
Email 11023 0
[email protected]
Contact person for scientific queries
Name 1951 0
Professor Paul Komesaroff
Address 1951 0
Monash University
Department of Medicine
Alfred Hospital
Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 1951 0
Australia
Phone 1951 0
+61 3 99030622
Fax 1951 0
Email 1951 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.