ACTRN12605000364673
Recruiting
Phase 3
The effects of nutritional supplementation on premenstrual syndrome
Swisse Bio-juven0 sites120 target enrollmentSeptember 12, 2005
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Premenstrual Syndrome
- Sponsor
- Swisse Bio-juven
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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