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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05452577
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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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 .

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

Detailed Description:
All subjects giving written informed consent. In this multicenter, controlled, prospective cohort study, the outpatient and inpatient chronic insomnia patients' baseline demographic data were collected, including age, gender, education background, and medication history. Venous blood samples were collected and sent to laboratory test for blood routine, and blood biochemistry at Baseline and Week 4. The Pittsburgh sleep quality index (PSQI) was used to assess the patients' sleep quality at baseline and week 4. Objective sleep quality data is assessed by wearing a Sleep wearable devices. The classic Morningness-Eveningness Questionnaire and wearable devices was used to assess the patients' chronotype at baseline and week 4.Subjects who visit the TCM clinic of this project received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks. Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient. Subjects from TCM clinic who had previously taken Western medicine hypnotics continued taking them, and for those who had not taken before, Western medicine hypnotics shall not be given/prescribed. Subjects who visit the Western medicine clinic of this project received Estazolam 1mg tablet orally once daily for 4 weeks. The participants will have a follow-up visit every two weeks, and the prescription would be adjusted according to the condition of illness.Cessation rate of Western medicine hypnotics was assessed at Month 6.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines
Drug Information available for: Estazolam

Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • Estazolam
  • Estazolam Tablets
  • Estazolam Pill


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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.


Secondary Outcome Measures :
  1. Change from Baseline of the ALT at 4 weeks [ Time Frame: Baseline and Week 4 ]
    Alanine aminotransferase, ALT in U/L

  2. Change from Baseline of the AST at 4 weeks [ Time Frame: Baseline and Week 4 ]
    Aspartate aminotransferase, AST in U/L

  3. Change from Baseline of the BUN at 4 weeks [ Time Frame: Baseline and Week 4 ]
    Blood urea nitrogen, BUN in mmol/L

  4. Change from Baseline of the Scr at 4 weeks [ Time Frame: Baseline and Week 4 ]
    Serum creatinine, Scr in μmol/L

  5. 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)

  6. 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.

  7. Change from baseline objective sleep quality [ Time Frame: Baseline and Week 4 ]
    Objective sleep quality data is assessed by wearing a Sleep wearable devices


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xiuqin Wang, doctor +86-25-68306156 xiuqinw@126.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 224000
Contact: Xiuqin Wang, doctor    +86-25-68306156    xinqinw@126.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Xiuqin Wang, doctor The First Affiliated Hospital with Nanjing Medical University
More Information
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT05452577    
Other Study ID Numbers: 2021-SR-015
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Estazolam
Anticonvulsants
Anti-Anxiety Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action