The effects of nutritional supplementation on premenstrual syndrome
- Conditions
- Premenstrual SyndromeReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12605000364673
- Lead Sponsor
- Swisse Bio-juven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 120
1. Subject has a regular menstrual cycle of 25 to 35 days. 2. Subject's general health is normal. 3. Subject has had symptoms of PMS in the last year. 4. Subject is willing to cease taking other supplements for the period of the trail. 5. Subject is willing to comply with the study protocol.
1. Subject is currently pregnant or lactating. 2. Subject who is of childbearing age who is not surgically sterile, who is 1) not using effective contraception, and 2) 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>Luteal Phase Score â¿¿ Follicular Phase Score x 100<br>Luteal Phase Score<br><br>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 Outcome Measures
Name Time Method 1. Serum magnesium ion[Laboratory investigation of the following parameters would be undertaken at two points during the study at commencement of treatment and at completion. Blood will be taken for safety monitoring and the following study parameters in the treatment cohort.];2. Serum calcium ion concentration.[Laboratory investigation of the following parameters would be undertaken at two points during the study at commencement of treatment and at completion. Blood will be taken for safety monitoring and the following study parameters in the treatment cohort.];Quality of life will be assessed with the SF-12 questionnaire.[]