NCT06244277|Unknown
Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal
Research on High-efficiency of Treatment of Adolescent Sleep Disorders Technology and Sleeping Pills Withdrawal
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Research on High-efficiency of Treatment of Adolescent Sleep Disorders Technology and Sleeping Pills Withdrawal
Sponsor study identifier
interventional
106
1 country
1
Study Start
December 22, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the safety and efficacy of traditional Chinese medicine in the treatment of adolescent sleep disorders and the effect of sleeping pills withdrawal.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2023
Actual (reported)January 15, 2024
Actual (reported)February 6, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1
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 Month 1
Insomnia severity index ( ISI ) score reduction rate at Month 1
Insomnia severity index ( ISI ) is to assess the nature and symptoms of sleep disorders in subjects. Score reduction rate of Insomnia severity index ( ISI )=(Baseline number-Month 1number)/Baseline number of participants
Month 1
Cessation rate of Western medicine hypnotics at Month 6
Month 6
Athens Insomnia Scale ( AIS ) score at Month 1
Baseline and Month 1
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
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 cognitive behavioral therapy, if for various reasons can not accept cognitive behavioral therapy, or have received cognitive behavioral therapy is not effective, according to the doctor to consider drug treatment, taking Zolpidem Tartrate Tablets 0.25mg/kg, the maximum dose was 10mg / day ; according to the doctor 's clinical consideration, anxiety and depression drugs can be added. For patients under 18 years of age, under the careful consideration of the doctor for drug treatment, taking Zolpidem tablets, 10mg / day
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
First Submitted
January 15, 2024
First Posted
February 6, 2024
Study Start
December 22, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)Zolpidem 10Mg Tab 10mg tablet once daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 6, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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