Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm
Sponsor study identifier
interventional
187
1 country
1
Study Start
January 22, 2021
Actual (reported)Primary Completion
May 30, 2023
Actual (reported)Study Completion
May 30, 2023
Actual (reported)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 .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2021
Actual (reported)July 6, 2022
Actual (reported)July 11, 2022
Actual (reported)May 30, 2023
Actual (reported)May 30, 2023
Actual (reported)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
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
Change from Baseline of the ALT at 4 weeks
Baseline and Week 4
Change from Baseline of the AST at 4 weeks
Baseline and Week 4
Change from Baseline of the BUN at 4 weeks
Baseline and Week 4
Change from Baseline of the Scr at 4 weeks
Baseline and Week 4
Genome-wide association study
Month 6
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.
Participants received Estazolam 1mg tablet orally once daily for 4 weeks.
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.
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 224000, China
Xiuqin Wang, doctor
The First Affiliated Hospital with Nanjing Medical University
187 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2022
First Posted
July 11, 2022
Study Start
January 22, 2021
Actual (reported)1mg tablet once daily
Contact the study team to confirm eligibility.
Primary Completion
May 30, 2023
Actual (reported)Study Completion
May 30, 2023
Actual (reported)Last Updated
February 28, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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