ITMCTR2023000013
Not yet recruiting
未知
A randomized, double-blind, controlled clinical study of Shuhe Granules in the treatment of chronic insomnia disorder
Guangdong Provincial hospital of Traditional Chinese Medicine0 sitesTBD
Conditionsinsomnia
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- insomnia
- Sponsor
- Guangdong Provincial hospital of Traditional Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Aged 18\-70
- •(2\) In line with Western medicine chronic insomnia diagnostic standards
- •It is consistent with the diagnostic criteria of chronic insomnia in the new edition of International Classification of Sleep Disorders? formulated by the American Academy of Sleep Medicine
- •(3\) Consistent with the indications of Shuhe granules:
- •Both of the following three
- •a. sleep difficulty factor score of Pittsburgh Sleep Quality Index \=1
- •b. daytime function factor score of Pittsburgh Sleep Quality Index \=1
- •c. Dizziness, palpitation, low menstrual volume, spontaneous sweating, fear of wind, cold limbs, white tongue, pale face, pale or reddish eyelids (symptoms \=3/8\).
- •None of the following cannot appear at the same time
- •a. The lower eyelid is completely red
Exclusion Criteria
- •1\.Preparing to become pregnant or during pregnancy or lactation;
- •2\. Secondary insomnia caused by physical disease. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.
- •3\. Secondary insomnia caused by mental disease. For example: Affective disorders, anxiety disorder, depression, schizophrenia, and any other serious mental disorders.
- •4\. A Patient health questionnaire\-9 (PHQ\-9\) score of 15 or higher;
- •5\. A Generalized Anxiety Scale (GAD\-7\) score of 15 or higher
- •6\. Use of medicine to treatment sleeping disorders in the past two week.
- •7\.Participants in clinical trials of other drugs in the past 30 days;
Outcomes
Primary Outcomes
Not specified
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