The effects of a nutritional supplementation on premenstrual syndrome

Phase 3

Completed

• Conditions: Premenstrual syndrome; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12605000406606
• Lead Sponsor: Swisse Bio Juven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants rated their symptoms daily using the Menstrual Health Questionnaire. From this data the mean daily scores from each follicular phase (cycle days 5 - 11, with day 1 being the first day of menstration) and each late luteal phase (days -1 to -7 from the next menstruation) were extracted so that the PMSS score could be calculated for each menstrual cycle[Rated on a daily basis]

Secondary Outcome Measures

Name	Time	Method
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