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Clinical Trials/ITMCTR2100004627
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

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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