An Interventional Clinical Study to Investigate the Effect of Oral Administration of Suanzaoren Decoction and Huanglian Wendan Decoction on Human Biorhythms in Patients With Insomnia

2023-SR-431

The purpose of this study was to examine the impact of Chinese medicine on melatonin levels in patients with insomnia

2023-08-31

2024-04-10

2024-04-10

Completed

19

Inclusion Criteria: * Age 18-55, male or female； * Insomnia patients: patients who met the diagnostic criteria for insomnia in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults (2017 edition) and who were judged to have moderate-to-severe insomnia according to the Insomnia Severity Index Scale; Healthy subjects: those who had normal sleep, and who met the scores of 0 to 7 on the Insomnia Severity Index Scale; * Informed consent, voluntary participation in the study； Exclusion Criteria: * People with mental illness; * Chronic insomnia with yang deficiency and yin deficiency, clinical manifestations: coldness of the whole body and hands and feet, like warmth and pressing, yellowish colour, unshaped stools, lumbago, weakness of the legs, nocturia, pale tongue with thin white moss; * Pregnant, lactating women; * Have a serious primary heart, liver, lung, kidney, haematological or serious disease affecting their survival, e.g. tumour or AIDS, SCr \> 1.5N (N is the upper limit of normal), ALT \> 2N (N is the upper limit of normal), blood leucocytes \< 3.0 x 109/L; * Participants in any other clinical trial within 3 months prior to dosing; * Those who are vulnerable to missing visits based on other circumstances that the researcher judges to be unsuitable for enrolment, such as changes in the work environment.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

2024-06-21