ITMCTR2024000035
Not yet recruiting
未知
A single-center, double-blind, randomized, placebo-controlled clinical study of Shuhe granule in the treatment of chronic insomnia with qi-blood disharmony and deficiency of both heart and kidney
Guangdong Provincial Hospitai of Chinese Medicine0 sitesTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Guangdong Provincial Hospitai of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) 18 to 65 years of age.
- •(2\) meet the diagnostic criteria of chronic insomnia in western medicine.
- •(3\) meet the diagnostic criteria of insomnia in traditional Chinese medicine.
- •(4\) consistent with the syndrome of disharmony between qi and blood and deficiency of both heart and kidney.
- •(5\) sign the informed consent form.
Exclusion Criteria
- •(1\) comply with any one of the excluded symptoms.
- •a. The lower eyelid is all red.
- •b. The hands are hot.
- •c. Stool dry knot, hard.
- •d. Thick, greasy or dry rough moss.
- •e. The pulse\-to\-interest ratio is greater than 5\.
- •(2\) people who are preparing for pregnancy or pregnancy or lactation or who need to accompany their children to sleep.
- •(3\) according to medical history and consultation, doctors confirm secondary insomnia caused by other diseases. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.
- •(4\) patients with severe depression were diagnosed according to the depression screening tool (PHQ\-9\) (total score \= 15\).
- •(5\) patients with severe anxiety were diagnosed according to the generalized anxiety disorder scale (GAD\-7\) (total score \= 15\).
Outcomes
Primary Outcomes
Not specified
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