Pre-menstrual syndrome Urological and Genital Diseases Premenstrual syndrome (PMS)
Conditions
Interventions
The active group is taking calcium and magnesium, and a multivitamin and mineral supplement and control will take 2 placebo tablets
one will be the same size and shape as the calcium and magnesium supplement, and the second will be the same size and shape as the multivitamin and mineral supplement and contain sufficient riboflavin
Sponsors
Swisse Vitamins Pty Ltd (Australia)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Subject has a regular menstrual cycle of 25 to 35 days 2. Subject is aged over 18 and less than 45 years 3. Subject?s general health is normal 4. Subject has had symptoms of PMS in the last year 5. Subject is willing to cease taking other supplements for the period of the trial 6. Subject is willing to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Subject is currently pregnant or lactating 2. Subject who is of childbearing age who is not surgically sterile, who is: a. Not using effective contraception b. Does not agree to have a pregnancy test monthly during the study 3. Subject is currently taking regular medication or dietary supplement(s) and is unwilling to cease 4. Subject self reports that they are experiencing undue stress/relationship problems 5. Subject has any significant disease or disorder 6. Subject is currently undergoing treatment for PMS 7. Subject commenced oral contraceptives in the three months prior to commencement 8. Subject changed oral contraceptives in the three months prior to commencement 9. Subject has had adverse effects from supplements and/or drugs 10. Subjects who are taking steroids 11. Subjects with parathyroid disorders 12. Subjects with thyroid disorders 13. Subjects with affective disorders 14. Subjects who experience photosensitive skin reactions or hypersensitivity to ginger 15. Any disease particularly conditions that interact with gonadotrophins or their releasing factors and those that compromise digestion or absorption of micronutrients 16. Any significant health complaint, problem or disease that in the opinion of the researcher would compromise the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure for PMS is the Premenstrual Symptom Complex Score, (derived from the Menstrual Health Questionnaire). This is assessed from the means of 23 daily individual symptom ratings and is calculated as shown below. Luteal Phase Score ? Follicular Phase Score x 100 Luteal Phase Score Efficacy is defined as a 20% difference between the premenstrual symptom complex score of those on either of two different dietary supplements compared to those on the placebo. Subjects will record these details in a daily diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Australia
Outcome results
None listed