DRKS00009005已完成未知
A three months intake of soy lecithin phosphatidylserine/phosphatidic acid complex (PAS) and effects on the premenstrual syndrome (PMS) - L4-2015
ipogen Ltd.0 个研究点目标入组 48 人开始时间: 2015年8月5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
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •PMS diagnosis;
- •Regular menstrual cycle with a constant cycle duration (25-35 days);
- •Easy access to computer and internet at home
排除标准
- •Known allergies to ingredients of the test substance;
- •Any further psychiatric diseases (e.g. major depressive disorder) as assessed with the Mini-DIPS;
- •Current intake of any drugs besides thyroid medication (TSH values in the normal range, lab results not older than 12 months) and blood pressure medication (stable for 6 months);
- •Intake of nutritional supplements or homeopathic remedies within the two weeks prior to V1;
- •Any current / acute disease besides thyroid
- •Any disease besides minor medical conditions (e.g. seasonal allergies);
- •Females working on nightshifts;
- •Females on a strict diet or practicing extensively sports;
- •Females smoking more than 5 cigarettes/week;
- •Pregnant or lactating;
- •Females planning a pregnancy in the next 12 months;
- •Employee of the sponsor or CRO;
- •Investigator doubts truthfulness of self-reported health information;
- •Females otherwise apparently unsuited (lack of cognitive or verbal skills);
- •Females currently participating in another clinical study
研究者
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