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Trial registered on ANZCTR


Trial ID
ACTRN12605000406606
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
14/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a nutritional supplementation on premenstrual syndrome
Scientific title
The effects of a nutritional supplementation on premenstrual syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual syndrome 512 0
Condition category
Condition code
Reproductive Health and Childbirth 591 591 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Swisse Ultivite for Women. The treatment was delivered for 4 months aver 4 menstrual cycles.
Intervention code [1] 262 0
Treatment: Other
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 686 0
Participants rated their symptoms daily using the Menstrual Health Questionnaire. From this data the mean daily scores from each follicular phase (cycle days 5 - 11, with day 1 being the first day of menstration) and each late luteal phase (days -1 to -7 from the next menstruation) were extracted so that the PMSS score could be calculated for each menstrual cycle
Timepoint [1] 686 0
Rated on a daily basis
Secondary outcome [1] 1402 0
None
Timepoint [1] 1402 0

Eligibility
Key inclusion criteria
Healthy women with regular menstrual cycles of 25 - 35 days. Women who defined themselves as experiencing premenstrual syndrome regularly during the previous 12 months. Individuals who agreed to avoid all nutritional supplements during their involvement in the trial. Individuals who agreed to record all medications used throughout the study.
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who were lactating or had stopped lactating within 3 months of commencement of the study. Subjects who had changed their use of oral contraceptives within 3 months of commencement of the study. Subjects who were undergoing treatment for PMS. Subjects who were taking regular medication. Subjects who were experiencing any undue stress or relationship problem. Subjects who experience photosensitive skin reactions or hypersensitivity to ginger. Any disease particularly conditions that interact with gonadotrophins or their releasing factors and those that compromise digestion or absorption of micronutrients. Any significant health complaint, problem or disease that in the opinion of the researcher would compromise the study.

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



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 645 0
Commercial sector/Industry
Name [1] 645 0
Swisse Bio Juven
Address [1] 645 0
Country [1] 645 0
Primary sponsor type
Commercial sector/Industry
Name
Swisse Bio Juven
Address
Country
Switzerland
Secondary sponsor category [1] 541 0
None
Name [1] 541 0
none
Address [1] 541 0
Country [1] 541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1772 0
Southern Cross University Human research Ethics Committee
Ethics committee address [1] 1772 0
Ethics committee country [1] 1772 0
Australia
Date submitted for ethics approval [1] 1772 0
Approval date [1] 1772 0
Ethics approval number [1] 1772 0

Summary
Brief summary
A randomised, double blind, placebo controlled trial was conducted over 42 weeks using parallel groups of individuals with prospectively confirmed mild to moderate premenstrual tension. The primary outcome measure was the Premenstrual Symptom Score (PMSS) assessed by questionnaire. Women were initially enrolled based on the Menstrual Health Questionnaire results taken at baseline. They then completed the assessment instrument each day for 2-3 menstrual cycles. Subjects were then excluded if they did not demonstrate a 30% increase in premenstrual symptoms between the follicular and luteal phases of 2 consecutive cycles. Only subjects meeting these criteria were randomised for the intervention phase.

The treatment arms were 1) Swisse Ultivite for Women and 2) placebo. Minimal side effects were reported during the treatment period. Initial consideration of the data pertaining to liver, renal and hemopoietic function showed no clinically significant changes.

There were significant reductions in premenstrual syndrome symptoms between the pre-treatment and post treatment stages of the study for both the placebo and active treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35878 0
Address 35878 0
Country 35878 0
Phone 35878 0
Fax 35878 0
Email 35878 0
Contact person for public queries
Name 9451 0
Professor Stephen Myers
Address 9451 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9451 0
Australia
Phone 9451 0
+61 2 66203403
Fax 9451 0
+61 2 66203307
Email 9451 0
smyers@scu.edu.au
Contact person for scientific queries
Name 379 0
Joan O'Connor
Address 379 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 379 0
Australia
Phone 379 0
+61 2 66203649
Fax 379 0
+61 2 66203307
Email 379 0
joconnor@scu.edu.au