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

Phase 1

Recruiting

• Conditions: Perimenopausal syndrome insomnia with depression and anxiety

• Registration Number: ITMCTR2022000043
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified