Clinical trial NCT04448197: Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm
Official title: The Real World Study on of Insomnia Treated by Traditional Chinese Medicine and Observation of Its Correlation With Circadian Rhythm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traditional Chinese Medicine
Insomnia
Circadian Rhythm
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1
timeFrame: Baseline and month 1
measure: Change from Baseline in the total score of the 17-item Hamilton Depression Scale (HAMD-17) at Month 1
timeFrame: Baseline and month 1
Secondary outcomes:
measure: Change in of the ALT，to evaluate the safety of TCM treatment
timeFrame: Baseline and month 1
measure: Change in of the AST，to evaluate the safety of TCM treatment
timeFrame: Baseline and month 1
measure: Change in of the BUN，to evaluate the safety of TCM treatment
timeFrame: Baseline and month 1
measure: Change in of the Scr，to evaluate the safety of TCM treatment
timeFrame: Baseline and month 1
measure: Change in of the Hcy，to evaluate the safety of TCM treatment
timeFrame: Baseline and month 1
measure: Genome-wide association study，in bp，to explore the correlation between insomnia and circadian rhythm of biological clock
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiuqin Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: