Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

NCT04448197 | Completed

• 1 other identifier: 2019-SR-484
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Traditional Chinese Medicine; Insomnia; Circadian Rhythm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in of the ALT，to evaluate the safety of TCM treatment

  Baseline and month 1

• Change in of the AST，to evaluate the safety of TCM treatment

  Baseline and month 1

• Change in of the BUN，to evaluate the safety of TCM treatment

  Baseline and month 1

• Change in of the Scr，to evaluate the safety of TCM treatment

  Baseline and month 1

• Change in of the Hcy，to evaluate the safety of TCM treatment

  Baseline and month 1

Interventions

Chinese Medicine OTHER

Dialectical treatment of traditional Chinese medicine according to different constitution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 224000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Routine blood test

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Xiuqin Wang, doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: June 25, 2020
• Study Start: March 4, 2020
• Primary Completion: October 16, 2020
• Study Completion: January 30, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CN (1)