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临床试验/ITMCTR2022000043
ITMCTR2022000043招募中1 期

Clinical observation of the treatment of heart-kidney incompatibility perimenopausal syndrome insomnia with symptoms of depression and anxiety

Xiyuan Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新:
适应症

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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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