Cognitive Behavioral Therapy combined Shugananshen granule in the treatment of insomnia
- Conditions
- Insomnia
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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;
(11) Those who cannot complete the experiment or the researcher thinks they cannot be selected for other reasons.
(12) Those who participated in other clinical trials within the past 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index Questionnaire;
- Secondary Outcome Measures
Name Time Method Actigraphy;Traditional Chinese Medicine Syndrome Scale;Dysfunctional Beliefs and Attitudes about Sleep;Insomnia Severity Index;