Chronic Insomnia Clinical Trial
Official title:
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
Verified date | June 2024 |
Source | The First Affiliated Hospital with Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to examine the impact of Chinese medicine on melatonin levels in patients with insomnia
Status | Completed |
Enrollment | 19 |
Est. completion date | April 10, 2024 |
Est. primary completion date | April 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from Baseline in melatonin concentration at Week 4 | The level of melatonin in the body | Baseline and Week 4 | |
Secondary | Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks | The Pittsburgh sleep quality index (PSQI) is a validated,self-reported instrument assessing the sleep quality over the past 4 week period. Possible scores range from 0(the best sleep quality) to 21(the worst possible sleep) quality).The higher the score of PSQI, the worse the sleep quality. Change=(Month 1 Score-Baseline Score) | Baseline and Week 4 | |
Secondary | Change from Baseline in the total score of Morning and Evening Questionnaire (MEQ) at 4 weeks | The Morning and Evening Questionnaire (MEQ) was used to evaluate the type of biological clock of subjects | Baseline and Week 4 |
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