ITMCTR2200006697尚未招募4 期
Clinical trial of Liuwei Anshen capsule in the treatment of perimenopausal insomnia
Hubei University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 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
- 40 至 60（—）
- 性别
- Female
入选标准
- •(1) It meets the diagnostic criteria for perimenopausal syndrome;
- •(2) It meets the diagnostic criteria for insomnia and the Syndrome Differentiation criteria of traditional Chinese medicine for insomnia (yin deficiency and fire excess with phlegm syndrome)
- •(3) Female, 40-60 years old;
- •(4) Be able to understand the content of the scale and actively cooperate with the treatment. Pittsburgh sleep quality index (PSQI) = 7 points
- •(5) Sign the informed consent form.
排除标准
- •(1) Not yet effectively controlled or severe disease (as judged by clinicians), such as persistent pain from various causes, malignancy, cardio cerebrovascular disease (hypertension, coronary atherosclerotic heart disease, cerebral infarction, brain trauma, Parkinson, dementia, epilepsy, etc.), endocrine disease (diabetes, hyperthyroidism, hypothyroidism, etc.) Patients with insomnia due to neuromuscular disorders and digestive disorders (gastroesophageal reflux, etc.).
- •(2) Those with moderate or severe anxiety and depression, psychiatric (HAMD = 20 and HAMA = 14).
- •(3) Pregnant and lactating patients.
- •(4) Involved in other clinical observers.
- •(5) Patients undergoing hormone replacement therapy.
- •(6) Other reason (s) the investigator considered not appropriate to participate in the clinical trial.
研究者
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