Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

NCT ID: NCT04448197

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-04
• Study Completion Date: 2021-01-30

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.

Conditions

Traditional Chinese Medicine; Insomnia; Circadian Rhythm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Chinese Medicine

Dialectical treatment of traditional Chinese medicine according to different constitution

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xiuqin Wang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuqin Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2019-SR-484

Identifier Type: -

Identifier Source: org_study_id