The effects of nutritional supplementation on premenstrual syndrome (PMS)
- Conditions
- Pre-menstrual syndromeUrological and Genital DiseasesPremenstrual syndrome (PMS)
- Registration Number
- ISRCTN48058420
- Lead Sponsor
- Swisse Vitamins Pty Ltd (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 140
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
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
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>Luteal Phase Score ? Follicular Phase Score x 100 Luteal Phase Score<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 o secondary outcome measures