Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm
Condition: Traditional Chinese Medicine; Insomnia; Circadian Rhythm
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      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 .
    

Detailed description: 
      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.
    

Intervention name(s): Chinese Medicine
Intervention type(s): Other
Intervention description(s): Dialectical treatment of traditional Chinese medicine according to different constitution
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients or inpatients of The First Affiliated Hospital of Nanjing Medical University
        (Jiangsu Province Hospital) ，age 18-75 years old, male and female unlimited，in line with
        the Chinese adult insomnia diagnosis and treatment guidelines (2017 version) insomnia
        diagnosis standards， informed consent, voluntary participation in this study.
      
Biospecimen description: 
      Routine blood test