None listed
Conditions
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.
Interventions
Swisse Ultivite for Women. The treatment was delivered for 4 months aver 4 menstrual cycles.
Sponsors
Swisse Bio Juven
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed