Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000021572
Ethics application status
Approved
Date submitted
12/01/2006
Date registered
13/01/2006
Date last updated
13/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
30Plus Study
Scientific title
The effect of 30Plus on Premenstrual Syndrome: a randomised controlled study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prementrual syndrome 982 0
Condition category
Condition code
Reproductive Health and Childbirth 1057 1057 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group would be women randomised into a group that will receive the 30Plus and
Intervention code [1] 837 0
None
Comparator / control treatment
control group would include women randomised into a group that will receive the placebo/control treatment for 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 1414 0
To exam the difference between the active and placebo treatment’s total 21-DASS scores
Timepoint [1] 1414 0
At each month of the treatment during 3 month period of the study
Secondary outcome [1] 2500 0
To examine the impact of this treatment on measuring the DASS sub-scores and the physical symptoms of PMS.
Timepoint [1] 2500 0
At each month of the treatment during 3 month period of the study.

Eligibility
Key inclusion criteria
Have at least one of these psychological and physical symptoms during the 5 days before menses: Psychology: Depression, angry outbursts, irritability, anxiety, confusion or social withdrawal.Physical: Breast tenderness, abdominal bloating, headache, swelling of extremities.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Usage of hormonal therapies such as hormone replacement therapy (HRT) or the oral contraceptive pill (OCP), Usage of herbals and vitamins known to have an effect on PMS, Severe depression.

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)
Code on medication container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised by computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1157 0
Self funded/Unfunded
Name [1] 1157 0
Country [1] 1157 0
Primary sponsor type
Commercial sector/Industry
Name
Natural Health Products
Address
Country
Australia
Secondary sponsor category [1] 1016 0
None
Name [1] 1016 0
no
Address [1] 1016 0
Country [1] 1016 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35851 0
Address 35851 0
Country 35851 0
Phone 35851 0
Fax 35851 0
Email 35851 0
Contact person for public queries
Name 10026 0
Ms Jinzhu Liu
Address 10026 0
Sydney Menopause Centre
Royal Hospital for Women
Level 0
Barker Street
Randwick NSW 2031
Country 10026 0
Australia
Phone 10026 0
+61 2 93826702
Fax 10026 0
Email 10026 0
[email protected]
Contact person for scientific queries
Name 954 0
Associate Professor John Eden
Address 954 0
Sydney Menopause Centre
Royal Hospital for Women
Level 0
Barker Street
Randwick NSW 2031
Country 954 0
Australia
Phone 954 0
+61 2 93826777
Fax 954 0
Email 954 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.