A randomized, double-blind, placebo-controlled study of Jieyu Xifeng Decoction in the treatment of anxiety insomnia
- Conditions
- Insomnia comorbid anxiety disorder
- Registration Number
- ITMCTR2000003796
- Lead Sponsor
- Shanghai Hospital of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. According to the diagnostic criteria of Western medicine for insomnia;
2. According to the TCM diagnostic criteria of insomnia;
3. The age is 18-70 years old;
4. PSQI score > 11, Spiegel Sleep Scale (improved) score > 12,HAMA score >= 14, and HAMA < 30;
5. No traditional Chinese medicine or western medicine was used to treat insomnia symptoms in the past month, or other drugs were taken in a short time (1 week), but no effect was found;
6. Those who voluntarily participate in this clinical study, are willing to receive treatment in accordance with the prescribed course of treatment, and can sign informed consent.
1. Patients with depression, severe anxiety, bipolar disorder, schizophrenia, aphasia and other serious, neuropsychiatric diseases, accompanied by thyroid function, hypertension, coronary heart disease and with serious heart, liver, kidney or other serious organic damage disease;
2. Pregnant and lactating women;
3. Subjects taking sleeping pills, antidepressants, etc.;
4. Those who fail to treat according to the specified requirements, and fill in incomplete information, etc. can not accurately judge the curative effect.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HAMA score;PSQI score;
- Secondary Outcome Measures
Name Time Method