Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal

NCT06244277 | Unknown

• 1 other identifier: 2023-SR-850
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traditional Chinese Medicine; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• 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

Study Arms (2)

Chinese medicine group

EXPERIMENTAL

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

Western medicine group

ACTIVE COMPARATOR

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

Drug: Zolpidem

Interventions

Suanzaoren Decoction and Huanglian Wendan Decoction DRUG

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.

Chinese medicine group

Zolpidem DRUG

Zolpidem 10Mg Tab 10mg tablet once daily

Western medicine group

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Outpatients or inpatients.
• It meet the diagnostic criteria of ' International Classification of Sleep Disorders, Third Edition ' ( ICSD-3 )..
• Informed consent, voluntary participation in the study.

You may not qualify if:

• Sleep disorders are caused by systemic diseases such as body pain, fever, cough, surgery and external environmental interference.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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 224000, China

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xiuqin Wang, doctor

CONTACT

+86-25-68306156; xiuqinw@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 6, 2024
• Study Start: December 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)