ITMCTR2000003635尚未招募1 期
Clinical study on the treatment of Perimenopausal Insomnia with Yishen Pinggan Decoction
Shanghai Municipal Hospital Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 45 至 60（—）
- 性别
- Female
入选标准
- •1.Women aged 45-60 years;
- •2.Insomnia;
- •3.Perimenopausal symptoms;
- •4.PSQI>= 6and KI>=15;
- •5.No sedatives and sleeping pills,or Stop taking sleeping pills more than two weeks.
排除标准
- •1. Premature ovarian failure or bilateral ovariectomy due to other diseases;
- •2. With mental illness;
- •3. HAMA >= 14 and(or) HAMD >= 18;
- •4. Obvious symptoms of heart, liver, kidney or other systems;
- •5. Laboratory examination and ECG examination have obvious clinical significance abnormalities, which can affect the drug evaluation or the safety of the subjects;
- •7. AST and ALT were 2.0 times higher than the upper limit of normal value;
- •8. Those who have severe allergic constitution or are known to be allergic to traditional Chinese medicine ingredients used in this study;
- •9. Those who have severe allergic constitution or known to be allergic to traditional Chinese medicine ingredients used in this study have received sex hormone drug treatment or participated in other clinical trials in the past one month.
研究者
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