Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448197
• Other study ID #: 2019-SR-484
• Status: Completed
• Start date: March 4, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: August 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 30, 2021
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circadian Rhythm
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Traditional Chinese Medicine

Intervention

Other:
• Chinese Medicine
Dialectical treatment of traditional Chinese medicine according to different constitution

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 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)	Baseline and month 1
Primary	Change from Baseline in the total score of the 17-item Hamilton Depression Scale (HAMD-17) at 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)	Baseline and month 1
Secondary	Change in of the ALT,to evaluate the safety of TCM treatment	Alanine aminotransferase, ALT in U/L.	Baseline and month 1
Secondary	Change in of the AST,to evaluate the safety of TCM treatment	Aspartate aminotransferase, AST in U/L	Baseline and month 1
Secondary	Change in of the BUN,to evaluate the safety of TCM treatment	Blood urea nitrogen, BUN in mmol/L	Baseline and month 1
Secondary	Change in of the Scr,to evaluate the safety of TCM treatment	Serum creatinine, Scr in µmol/L	Baseline and month 1
Secondary	Change in of the Hcy,to evaluate the safety of TCM treatment	Homocysteine, Hcy in µmol/L	Baseline and month 1
Secondary	Genome-wide association study,in bp,to explore the correlation between insomnia and circadian rhythm of biological clock	Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics (Reykjavi'k, Iceland)	1 year