Chronic Insomnia Clinical Trial
Official title:
Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm
Verified date | February 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 is to assess the safety and efficacy of Traditional Chinese medicine (TCM) according to Yin Yang theory for treatment of chronic insomnia .
Status | Completed |
Enrollment | 187 |
Est. completion date | May 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Outpatients or inpatients. - It conforms to the chronic insomnia diagnosis standard of Chinese adult insomnia diagnosis and treatment guide (2017 Edition). - Chronic insomnia patients with Yin yang imbalance and Ying Wei Disharmony Syndrome. - Informed consent, voluntary participation in the study. Exclusion Criteria: - Sleep apnea syndrome leads to insomnia. - Severe depression, suicidal tendency or having committed suicide. - Pregnant and lactating women. - It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as: tumor or AIDS, SCR > 1.5n (n is the upper limit of normal value), ALT > 2n (n is the upper limit of normal value), WBC < 3.0 × 109 / L; - Those who cannot give full informed consent due to mental disorders. - According to the researcher's judgment, other situations that are not suitable for the group, such as the change of working environment. - Subjects who are participating in other clinical studies. |
Country | Name | City | State |
---|---|---|---|
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 | 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 | |
Primary | Cessation rate of Western medicine hypnotics at Month 6 | Cessation was defined as an absence of any Western medicine hypnotics that was sustained for 3 consecutive months or more. Cessation rate of Western medicine hypnotics=(Month 6 number-Baseline number)/Baseline number of Participants use Western medicine hypnotics. | Month 6 | |
Secondary | Change from Baseline of the ALT at 4 weeks | Alanine aminotransferase, ALT in U/L | Baseline and Week 4 | |
Secondary | Change from Baseline of the AST at 4 weeks | Aspartate aminotransferase, AST in U/L | Baseline and Week 4 | |
Secondary | Change from Baseline of the BUN at 4 weeks | Blood urea nitrogen, BUN in mmol/L | Baseline and Week 4 | |
Secondary | Change from Baseline of the Scr at 4 weeks | Serum creatinine, Scr in µmol/L | Baseline and Week 4 | |
Secondary | Genome-wide association study | Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics(Reykjavi'k, Iceland) | Month 6 | |
Secondary | Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ) | The MEQ is a validated, self-reported questionaire assessing personal chronotype in the recent period. Possible scores range from 16 (extreme eveningness) to 86 (extreme morningness). Change = (Week 4 Score - Baseline Score). Positive score change indicates a shift from eveningness to morningness. | Baseline and Week 4 | |
Secondary | Change from baseline objective sleep quality | Objective sleep quality data is assessed by wearing a Sleep wearable devices | Baseline and Week 4 |
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