ISRCTN10128742已完成未知
Assessment of the efficacy of a food supplement in improving bone turnover markers and menopause-related symptoms in post-menopausal women: a double blind, randomized clinical study of efficacy and safety.
Paladin Pharma S.p.A.0 个研究点目标入组 60 人开始时间: 2016年4月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37569440/ (added 03/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy female subjects; Age: between 50 and 55 years old
- •2. Caucasian ethnicity
- •3. Body mass index between 20 and 25
- •4. Slightly overweight (10-20% than ideal weight)
- •5. Menopause onset (date of last menstrual cycle) not longer than 1 year from the date of study entry
- •6. Case history characterized by menopausal syndrome psychological complaints (anxiety, emotional instability, depression), hot flush, localized fat and body fat percentage increase
- •7. No participation in similar trials
- •8. Absence of disease
- •9. Agreement not to make any changes to the normal everyday routine
- •10. Agreement not to use during the study products with activity similar such than the tested product
- •11. Agreement not to make any changes to eating habits
- •12. Subjects informed of the trial procedures who have signed an informed consent form
排除标准
- •1. Subjects not satisfying the inclusion criteria
- •2. Subjects under local or systemic pharmacological treatment
- •3. Subjects who do not have endometrial hyperplasia in their case history
- •4. Hormone replacement therapy
- •5. Metabolic syndrome
- •6. Depressive syndrome not menopause related
- •7. Subjects with food intolerances
研究者
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