Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
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Updated on 5 August 2020
See if I qualify
psychotherapy
insomnia
somnolence
sleep disorder
drowsiness
traditional chinese medicine
sleeping pill
anterograde amnesia
sleeping

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 .

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.

Details
Condition Circadian Rhythm, Insomnia, Insomnia, Traditional Chinese Medicine
Age 18years - 75years
Treatment Chinese Medicine
Clinical Study IdentifierNCT04448197
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
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