ITMCTR2100004627
Recruiting
未知
Cognitive Behavioral Therapy combined Shugananshen granule in the treatment of insomnia: A Clinical Study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Meet the relevant diagnostic criteria for sleep disorders in ICD\-10;
- •(2\) PSQI scale test score \>\= 6 points;
- •(3\) Between 18 and 60 years old;
- •(4\) Sign the informed consent form;
- •(5\) Stable vital signs;
- •(6\) Conscious, able to cooperate to complete cognitive behavioral therapy.
Exclusion Criteria
- •(1\) Secondary insomnia ;
- •(2\) Hamilton Anxiety Scale (HAMA) total score \>\= 14 points;
- •(3\) Hamilton Depression Scale (HAMD, 17 items) total score \>\= 18 points;
- •(4\) Those taking psychoactive drugs (anti\-depressants, anti\-anxiety drugs, etc.) at the same time;
- •(5\) Those who have taken sleeping medicines and supplements (melatonin, etc.) regularly within 2 weeks before treatment or during the same period;
- •(6\) Those who have serious diseases such as cardiovascular, lung, liver, kidney, or hematopoietic system, endocrine system, mental illness, brain organic disease, drug abuse, or obvious visual or hearing impairment;
- •(7\) Laboratory examinations and ECG examinations have obvious clinically significant abnormalities, and according to the investigator's judgment, the abnormalities may affect the drug evaluation or the safety of the subjects;
- •(8\) Pregnant or lactating women;
- •(9\) Alcoholism or drug dependence;
- •(10\) Those who are allergic to the experimental drugs or ingredients contained in this protocol;
Outcomes
Primary Outcomes
Not specified
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