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NCT Number: NCT04448197

Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

Insomnia and sleep disorders are prominent health problems in modern society. High working pressure, fast pace of life, the use of electronic products and other reasons lead to the high incidence of insomnia and sleep disorders, which affect people's physical and mental health seriously, long-term insomnia will increase the risk of various health problems, and may even lead to malignant accidents. There are few effective methods to treat insomnia or sleep disorders, only part of the problem can be solved by sleeping pills and psychotherapy. However, drug therapy has side effects such as drowsiness on the next day, ataxia, anterograde amnesia and so on, and long-term application is addictive. Traditional Chinese medicine (TCM) has certain characteristics and advantages in the treatment of insomnia, but there is lack of evidence in clinical research that meets the requirements of modern evidence-based medicine, to prove the exact efficacy and safety of TCM in the treatment of insomnia. In addition, the research shows that the internal biological clock cycle of normal human body is 24-hour, insomnia may be related to biological clock gene. In this study, the outpatients with insomnia were taken as the research object. To observe the efficacy and safety of TCM in the treatment of insomnia by recording the participants' baseline demographic data, questionnaire survey, and conducting hematology examination. At the same time, to know the TCM constitution type of insomnia patients, through questionnaire survey with "Classification and Determination of TCM constitution table" that published by China Association of Chinese Medicine.And to explore the correlation between insomnia and circadian rhythm of biological clock .

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Key information

Conditions

Traditional Chinese Medicine Circadian Rhythm Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 224000, China

About this study

To record the demographic information and clinical characteristics of participants, including age, gender, education background, and drug use. Venous blood samples were collected and sent to laboratory test for blood routine, blood biochemistry, and blood homocysteine before and after 1 months of treatment. The remaining blood samples were kept in the sample bank for preservation. The Pittsburgh sleep quality index (PSQI) was used to evaluate the patients' sleep quality, and the depressive symptoms were assessed by Hamilton Depression Scale (HAMD-17) before and after treatment. Conduct the "Classification and Determination of TCM constitution table" before the treatment and 1-2 weeks before the end of the treatment, and according to the TCM constitution type to give constitution conditioning treatment.The participants will have a follow-up visit every two weeks, and the TCM will be adjusted according to the condition of illness. The treatment will last for 1 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients or inpatients.
  • It conforms to the insomnia diagnosis standard of Chinese adult insomnia diagnosis and treatment guide (2017 Edition).
  • 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 and other vulnerable interviewers.
  • Patients who are participating in other clinical studies.

Treatment and study plan

Chinese Medicine

Other

Dialectical treatment of traditional Chinese medicine according to different constitution

Primary outcomes

  1. Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1

    Time frame: Baseline and month 1

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 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. Change from Baseline in the total score of the 17-item Hamilton Depression Scale (HAMD-17) at Month 1

    Time frame: Baseline and month 1

    The 17-item Hamilton Depression Rating Scale(HAMD-17) assesses severity ranges of depression: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24). Possible scores range from 0(no depression) to 54(the worst possible depression). The higher the score of HAMD-17, the heavier the depression. Change=(Month 1 Score-Baseline Score)

Secondary outcomes

  1. Change in of the ALT，to evaluate the safety of TCM treatment

    Time frame: Baseline and month 1

    Alanine aminotransferase, ALT in U/L.

  2. Change in of the AST，to evaluate the safety of TCM treatment

    Time frame: Baseline and month 1

    Aspartate aminotransferase, AST in U/L

  3. Change in of the BUN，to evaluate the safety of TCM treatment

    Time frame: Baseline and month 1

    Blood urea nitrogen, BUN in mmol/L

  4. Change in of the Scr，to evaluate the safety of TCM treatment

    Time frame: Baseline and month 1

    Serum creatinine, Scr in μmol/L

  5. Change in of the Hcy，to evaluate the safety of TCM treatment

    Time frame: Baseline and month 1

    Homocysteine, Hcy in μmol/L

  6. Genome-wide association study，in bp，to explore the correlation between insomnia and circadian rhythm of biological clock

    Time frame: 1 year

    Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics (Reykjavı'k, Iceland)

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

The Real World Study on of Insomnia Treated by Traditional Chinese Medicine and Observation of Its Correlation With Circadian Rhythm

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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