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Traditional Chinese MedicineNCT04448197

Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm

An observational study of Traditional Chinese Medicine and Insomnia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Chinese Medicine
How many people
50 participants
Where
1 siteChina
Study dates
4 Mar 2020to 30 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 224000

Other trials in China

About this study

Official title: 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 .

Read the 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.

Being tested
Chinese Medicine
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chinese MedicineOther

    Dialectical treatment of traditional Chinese medicine according to different constitution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline and month 1

  2. 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)

    Measured: Baseline and month 1

Secondary outcomes (6)

  1. Change in of the ALT，to evaluate the safety of TCM treatment

    Alanine aminotransferase, ALT in U/L.

    Measured: Baseline and month 1

  2. Change in of the AST，to evaluate the safety of TCM treatment

    Aspartate aminotransferase, AST in U/L

    Measured: Baseline and month 1

  3. Change in of the BUN，to evaluate the safety of TCM treatment

    Blood urea nitrogen, BUN in mmol/L

    Measured: Baseline and month 1

  4. Change in of the Scr，to evaluate the safety of TCM treatment

    Serum creatinine, Scr in μmol/L

    Measured: Baseline and month 1

  5. Change in of the Hcy，to evaluate the safety of TCM treatment

    Homocysteine, Hcy in μmol/L

    Measured: Baseline and month 1

  6. 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)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start4 Mar 2020
  3. Primary completion16 Oct 2020
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448197
Sponsor's protocol ID
2019-SR-484
Status last verified
Aug 2021
First submitted
11 Feb 2020
Last updated
24 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Traditional Chinese Medicine and Insomnia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1 (time frame: Baseline and month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.

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