Alternative Treatments for Menopausal Women
Từ khóa
trừu tượng
Sự miêu tả
Menopausal symptoms are a common phenomenon causing discomfort to many middle aged women throughout the world. The core symptoms are experienced as hot flushes (HF), night sweats, vaginal dryness and sleep disturbance. Other secondary symptoms are sexual dysfunction, depression, anxiety, memory loss, fatigue, headache, joint pains and weight gain. Moreover there is increased risk of further complications such as osteoporosis, cardiovascular and negative changes in lipid profile associated with the reduction in oestrogen during and post menopause.
Trifolium Pratense or Red Clover (RC) has arisen as a popular source for women experiencing HF because it contains a variety of phytoestrogen's, namely isoflavones, lignans and coumestans. Phytoestrogens are shown to have positive effects on menopausal disorders such as breast cancer, cardiovascular risk factors, osteoporosis and have been shown to exert non-hormonal antioxidant effects. Additionally these isoflavones appear to reduce bone resorbtion, help maintain bone mineral density and improve lipid profile (reducing LDL: HDL, lipoprotein A, total cholesterol and may also reduce triglycerides).
RC is particularly high in estrogenic isoflavones biochanin A, formononetin and to a lesser degree genestein and diadzein, although the two former are precursors to genestein and diadzein. Asian populations with a high intake of soy (rich in genestein and diadzein) have long shown a lower reported incidence of the symptoms of menopause.
The study will be carried out as a 3-month parallel randomized control intervention study, consisting of 61 menopausal women. During summer 2012, 61 participants will be randomised into 2 groups (~30-31 in each group). The two groups are as follows:
1. Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)
2. Menopausal women receiving placebo - 150ml placebo
ngày
| Xác minh lần cuối: | 01/31/2015 |
| Đệ trình đầu tiên: | 07/11/2012 |
| Đăng ký ước tính đã được gửi: | 01/05/2014 |
| Đăng lần đầu: | 01/06/2014 |
| Cập nhật lần cuối được gửi: | 02/04/2015 |
| Cập nhật lần cuối đã đăng: | 02/05/2015 |
| Ngày bắt đầu nghiên cứu thực tế: | 05/31/2012 |
| Ngày hoàn thành chính ước tính: | 11/30/2014 |
| Ngày hoàn thành nghiên cứu ước tính: | 11/30/2014 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Dietary Supplement: Placebo
Dietary Supplement: Red Clover extract
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Active Comparator: Red Clover extract 150 ml/d Red Clover extract | Dietary Supplement: Red Clover extract Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day |
| Placebo Comparator: Placebo 150 ml/d sweetened and coloured water | Dietary Supplement: Placebo water with color |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 45 Years Đến 45 Years |
| Giới tính đủ điều kiện để nghiên cứu | Female |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: - Women aged 40-65 years - Experiencing daily hot flushes - Body Mass Index (BMI) between 20-40 - Irregular menstrual bleeding - FSH levels above the normal range Exclusion Criteria: - Simultaneous participation in other clinical trials within the last 3 months - Severe cardiovascular, psychiatric, neurological, and/or kidney disease. - Alcohol or drug abuse and acute illness. - Blood pressure > 160/110 - Pregnant and lactating women |
Kết quả
Các biện pháp kết quả chính
1. Primary Menopause-related symptoms [3 months]
