Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm
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|ClinicalTrials.gov Identifier: NCT05452577|
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : July 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia Circadian Rhythm Traditional Chinese Medicine||Drug: Suanzaoren Decoction and Huanglian Wendan Decoction Drug: Estazolam 1Mg Tab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm|
|Actual Study Start Date :||January 22, 2021|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: Chinese medicine group
Participants received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks.
Subjects who had previously taken Western medicine hypnotics continued to take them, and those who did not take them did not add Western medicine hypnotics.
Drug: Suanzaoren Decoction and Huanglian Wendan Decoction
Twice daily. Chinese herbal medicine includes: includes: 25 grams of Suanzaoren, 10 grams of chuanxiong, 30 grams of fushen, 10 grams of Polygala tenuifolia, 10 grams of Pinellia ternata, 12 grams of tangerine peel, 15 grams of Zhuru, 30 grams of forged keel, 30 grams of forged oyster,10 grams of aurantii fructus, 6 grams of coptis chinensis, 30 grams of Albizzia bark.Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient.
Other Name: Wild Jujube Seed Decoction and Huanglian Wendan Decoction
Active Comparator: Western medicine group
Participants received Estazolam 1mg tablet orally once daily for 4 weeks.
Drug: Estazolam 1Mg Tab
1mg tablet once daily
- Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks [ Time Frame: Baseline and Week 4 ]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)
- Cessation rate of Western medicine hypnotics at Month 6 [ Time Frame: 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.
- Change from Baseline of the ALT at 4 weeks [ Time Frame: Baseline and Week 4 ]Alanine aminotransferase, ALT in U/L
- Change from Baseline of the AST at 4 weeks [ Time Frame: Baseline and Week 4 ]Aspartate aminotransferase, AST in U/L
- Change from Baseline of the BUN at 4 weeks [ Time Frame: Baseline and Week 4 ]Blood urea nitrogen, BUN in mmol/L
- Change from Baseline of the Scr at 4 weeks [ Time Frame: Baseline and Week 4 ]Serum creatinine, Scr in μmol/L
- Genome-wide association study [ Time Frame: Month 6 ]Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics(Reykjavı'k, Iceland)
- Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ) [ Time Frame: Baseline and Week 4 ]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.
- Change from baseline objective sleep quality [ Time Frame: Baseline and Week 4 ]Objective sleep quality data is assessed by wearing a Sleep wearable devices
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05452577
|Contact: Xiuqin Wang, email@example.com|
|The First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 224000|
|Contact: Xiuqin Wang, doctor +86-25-68306156 firstname.lastname@example.org|
|Principal Investigator:||Xiuqin Wang, doctor||The First Affiliated Hospital with Nanjing Medical University|