Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

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

Study Overview

• Status: Completed
• Conditions: Insomnia; Circadian Rhythm; Traditional Chinese Medicine
• Intervention / Treatment: Other: Chinese Medicine

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 224000
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in of the ALT，to evaluate the safety of TCM treatment	Alanine aminotransferase, ALT in U/L.	Baseline and month 1
Change in of the AST，to evaluate the safety of TCM treatment	Aspartate aminotransferase, AST in U/L	Baseline and month 1
Change in of the BUN，to evaluate the safety of TCM treatment	Blood urea nitrogen, BUN in mmol/L	Baseline and month 1
Change in of the Scr，to evaluate the safety of TCM treatment	Serum creatinine, Scr in μmol/L	Baseline and month 1
Change in of the Hcy，to evaluate the safety of TCM treatment	Homocysteine, Hcy in μmol/L	Baseline and month 1
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 (Reykjavı'k, Iceland)	1 year

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2020
• Primary Completion (ACTUAL): October 16, 2020
• Study Completion (ACTUAL): January 30, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (ACTUAL): June 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2019-SR-484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No