A natural approach to treating premenstrual complaints: a randomized control trial comparing Vitamin B6 to a Broad Spectrum Micronutrient formula.
- Conditions
- Premenstrual syndrome (PMS)Women's mental healthMental Health - Other mental health disordersReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12615000131550
- Lead Sponsor
- niversity of Canterbury
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 80
For inclusion participants must be regularly menstruating females over the age of 18 (cycle length must last between 21-35 days) who have premenstrual syndrome (PMS) as determined by information given on the Daily Record of Severity of Problems questionnaire.
Cannot be pregnant or planning to become pregnant, no accompanying major mood disorder, cannot currently be taking medication for premenstrual syndrome (PMS). Participants with any of the following will be excluded: 1) neurological disorder involving brain or other central nervous system function (e.g., epilepsy), 2) pregnant or breastfeeding, 3) evidence of untreated or unstable thyroid disease, 4) any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 5) judged clinically to be at serious risk of suicide or violence, or 6) currently taking any other medication with primarily central nervous system activity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method