Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm

NCT05452577 | Completed

• 1 other identifier: 2021-SR-015
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Chronic Insomnia; Circadian Rhythm; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• 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

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 Estazolam 1mg tablet orally once daily for 4 weeks.

Drug: Estazolam 1Mg Tab

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.

Also known as: Wild Jujube Seed Decoction and Huanglian Wendan Decoction

Chinese medicine group

Estazolam 1Mg Tab DRUG

1mg tablet once daily

Also known as: Estazolam, Estazolam Tablets, Estazolam Pill

Western medicine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Estazolam

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiuqin Wang, doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: January 22, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)