Clinical Study on Zishui Bugan Decoction in Treating Insomnia of Liver-Kidney Deficiency in Menopause
- Conditions
- Insomnia
- Registration Number
- ITMCTR2100004814
- Lead Sponsor
- Chongqing Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1.The age of the patient is between 40 and 60 years old (including 40 years old and 60 years old);
2.Meet the diagnostic criteria of traditional Chinese and Western medicine for perimenopausal insomnia and the diagnostic criteria of TCM syndromes for liver and kidney yin deficiency;
3.Improved Kupperman scale > 5 points, Pittsburgh Sleep Quality Index (PSQI)> 7 points;
4.No sedatives and hypnotic drugs were taken at the time of enrollment, and no related non-drug treatments, such as cognitive behavioral therapy, music therapy, etc.; those who had taken sedatives and hypnotic drugs were enrolled after a 7-day washout period in advance;
5.Participants sign an informed consent form.
1.Patients under the age of 40 and over 60 years;
2.People with insomnia before the age of 40;
3.Insomnia caused by various diseases, environmental changes, and major changes;
4.Alcoholism and/or psychoactive drugs, drug abusers and dependents, as well as those who cannot stop taking Chinese medicines and sedative western medicines;
5.Estrogen replacement therapy;
6.Those who are allergic to the known ingredients of this medicine;
7.Combined with serious heart, brain, kidney, liver and other diseases.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Kupperman Index;Liver and Kidney Yin Deficiency TCM Scale;Pittsburgh sleep quality index;
- Secondary Outcome Measures
Name Time Method