ITMCTR2022000043招募中1 期
Clinical observation of the treatment of heart-kidney incompatibility perimenopausal syndrome insomnia with symptoms of depression and anxiety
适应症
试验速览
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 55(—)
- 性别
- Female
入选标准
- •1 perimenopausal female aged 45-55 years.
- •2 Meet the diagnostic criteria and scoring basis for insomnia, depression and anxiety.
- •3 Meet the diagnostic criteria of TCM dialectical heart-kidney incompatibility.
- •4There is no history of allergy to the drug under study.
- •5. Voluntarily participate in this study and sign an informed consent form.
排除标准
- •1 Patients with primary diseases such as cardiac, hepatic, and renal insufficiency are not suitable for patients participating in this experiment.
- •2 Patients with organic insomnia caused by insufficient cerebral blood supply, cardiovascular and cerebrovascular diseases, poisoning, and diseases of the five senses.
- •3 Patients with insomnia caused by other psychiatric disorders (in addition to perimenopausal depression and anxiety) or other factors such as various drugs.
- •4 Patients with severe depression and anxiety symptoms > 35 points on the Hamilton Depression Scale (24 items) and or the Hamiltonian Anxiety Scale (14 items) > 29 points.
- •5 ongoing and continuing hormone replacement therapy treatment or other TCM treatments; or patients who have undergone normative treatment for insomnia and depression and anxiety within the last 4 weeks.
- •6 There are bad living habits such as drug use, smoking, alcoholism, and long-term playing of mobile phones and computers at night, which may affect sleep.
- •7 Patients with severe organic gynecological diseases, such as cervical cancer, tumors, etc.
- •8 Patients with fertility needs.
- •9 Patients who take contraceptive rings containing estrogen and progesterone components such as Manyuele rings for contraception.
- •10 Patients with severe insomnia, depression, anxiety symptoms that affect life and need to take Western medicine.
- •11 patients with severe drug allergies.
研究者
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