The Use of D-chiro-inositol in the Treatment of AUB
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 主要终点
- AUB
研究概览
简要总结
Patients with AUB will undergo 6-month treatment with D-chiro-inositol and will fill in questionnaires on AUB, with the evaluation of hormonal serum levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Menopause
- •Cancer diagnosis
- •Atypical endometrial hyperplasia
- •Uterine fibroids
- •Heavy symptoms requiring pharmacological intervention
- •Progestogens treatment in the six months before the study
- •Inositol treatment in the six months before the study
研究组 & 干预措施
Treatment
Patients will undergo 3 months treatment with 1200 mg D-chiro-inositol and 120 mg lactalbumin, than 3 months treatment with 600 mg D-chiro-inositol and 60 mg lactalbumin
干预措施: D-chiro-inositol and lactalbumin (high dose) (Dietary Supplement)
Treatment
Patients will undergo 3 months treatment with 1200 mg D-chiro-inositol and 120 mg lactalbumin, than 3 months treatment with 600 mg D-chiro-inositol and 60 mg lactalbumin
干预措施: D-chiro-inositol and lactalbumin (low dose) (Dietary Supplement)
结局指标
主要结局
AUB
时间窗: 0, 3 and 6 months
The "Menstrual Bleeding Questionnaire", a standardized and validated questionnaire, will be administered to patients to evaluate te extent of AUB and the impact on their quality of life.
次要结局
- Serum level of Triglyceride(0, 3 and 6 months)
- Serum level of Testosterone(0, 3 and 6 months)
- Serum level of High-Density Lipoprotein(0, 3 and 6 months)
- Serum level of Low-Density Lipoprotein(0, 3 and 6 months)
- Serum level of Estradiol(0, 3 and 6 months)
- Serum level of Estrone(0, 3 and 6 months)
- Serum level of Androstenedione(0, 3 and 6 months)
- Serum level of Total cholesterol(0, 3 and 6 months)
研究者
Sandro Gerli
Professor
University Of Perugia