<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448197</url>
  </required_header>
  <id_info>
    <org_study_id>2019-SR-484</org_study_id>
    <nct_id>NCT04448197</nct_id>
  </id_info>
  <brief_title>Insomnia Treated by Traditional Chinese Medicine and Its Circadian Rhythm</brief_title>
  <official_title>The Real World Study on of Insomnia Treated by Traditional Chinese Medicine and Observation of Its Correlation With Circadian Rhythm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insomnia and sleep disorders are prominent health problems in modern society. High working&#xD;
      pressure, fast pace of life, the use of electronic products and other reasons lead to the&#xD;
      high incidence of insomnia and sleep disorders, which affect people's physical and mental&#xD;
      health seriously, long-term insomnia will increase the risk of various health problems, and&#xD;
      may even lead to malignant accidents. There are few effective methods to treat insomnia or&#xD;
      sleep disorders, only part of the problem can be solved by sleeping pills and psychotherapy.&#xD;
      However, drug therapy has side effects such as drowsiness on the next day, ataxia,&#xD;
      anterograde amnesia and so on, and long-term application is addictive. Traditional Chinese&#xD;
      medicine (TCM) has certain characteristics and advantages in the treatment of insomnia, but&#xD;
      there is lack of evidence in clinical research that meets the requirements of modern&#xD;
      evidence-based medicine, to prove the exact efficacy and safety of TCM in the treatment of&#xD;
      insomnia. In addition, the research shows that the internal biological clock cycle of normal&#xD;
      human body is 24-hour, insomnia may be related to biological clock gene. In this study, the&#xD;
      outpatients with insomnia were taken as the research object. To observe the efficacy and&#xD;
      safety of TCM in the treatment of insomnia by recording the participants' baseline&#xD;
      demographic data, questionnaire survey, and conducting hematology examination. At the same&#xD;
      time, to know the TCM constitution type of insomnia patients, through questionnaire survey&#xD;
      with &quot;Classification and Determination of TCM constitution table&quot; that published by China&#xD;
      Association of Chinese Medicine.And to explore the correlation between insomnia and circadian&#xD;
      rhythm of biological clock .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To record the demographic information and clinical characteristics of participants, including&#xD;
      age, gender, education background, and drug use. Venous blood samples were collected and sent&#xD;
      to laboratory test for blood routine, blood biochemistry, and blood homocysteine before and&#xD;
      after 1 months of treatment. The remaining blood samples were kept in the sample bank for&#xD;
      preservation. The Pittsburgh sleep quality index (PSQI) was used to evaluate the patients'&#xD;
      sleep quality, and the depressive symptoms were assessed by Hamilton Depression Scale&#xD;
      (HAMD-17) before and after treatment. Conduct the &quot;Classification and Determination of TCM&#xD;
      constitution table&quot; before the treatment and 1-2 weeks before the end of the treatment, and&#xD;
      according to the TCM constitution type to give constitution conditioning treatment.The&#xD;
      participants will have a follow-up visit every two weeks, and the TCM will be adjusted&#xD;
      according to the condition of illness. The treatment will last for 1 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2020</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">October 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in the total score of the 17-item Hamilton Depression Scale (HAMD-17) at Month 1</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in of the ALT，to evaluate the safety of TCM treatment</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>Alanine aminotransferase, ALT in U/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in of the AST，to evaluate the safety of TCM treatment</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>Aspartate aminotransferase, AST in U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in of the BUN，to evaluate the safety of TCM treatment</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>Blood urea nitrogen, BUN in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in of the Scr，to evaluate the safety of TCM treatment</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>Serum creatinine, Scr in μmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in of the Hcy，to evaluate the safety of TCM treatment</measure>
    <time_frame>Baseline and month 1</time_frame>
    <description>Homocysteine, Hcy in μmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genome-wide association study，in bp，to explore the correlation between insomnia and circadian rhythm of biological clock</measure>
    <time_frame>1 year</time_frame>
    <description>Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics (Reykjavı'k, Iceland)</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Traditional Chinese Medicine</condition>
  <condition>Insomnia</condition>
  <condition>Circadian Rhythm</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chinese Medicine</intervention_name>
    <description>Dialectical treatment of traditional Chinese medicine according to different constitution</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Routine blood test&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatients or inpatients of The First Affiliated Hospital of Nanjing Medical University&#xD;
        (Jiangsu Province Hospital) ，age 18-75 years old, male and female unlimited，in line with&#xD;
        the Chinese adult insomnia diagnosis and treatment guidelines (2017 version) insomnia&#xD;
        diagnosis standards， informed consent, voluntary participation in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients or inpatients.&#xD;
&#xD;
          -  It conforms to the insomnia diagnosis standard of Chinese adult insomnia diagnosis and&#xD;
             treatment guide (2017 Edition).&#xD;
&#xD;
          -  Informed consent, voluntary participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sleep apnea syndrome leads to insomnia.&#xD;
&#xD;
          -  Severe depression, suicidal tendency or having committed suicide.&#xD;
&#xD;
          -  Pregnant and lactating women.&#xD;
&#xD;
          -  It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting&#xD;
             its survival, such as: tumor or AIDS, SCR &gt; 1.5n (n is the upper limit of normal&#xD;
             value), ALT &gt; 2n (n is the upper limit of normal value), WBC &lt; 3.0 × 109 / L;&#xD;
&#xD;
          -  Those who cannot give full informed consent due to mental disorders.&#xD;
&#xD;
          -  According to the researcher's judgment, other situations that are not suitable for the&#xD;
             group, such as the change of working environment and other vulnerable interviewers.&#xD;
&#xD;
          -  Patients who are participating in other clinical studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiuqin Wang, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>224000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 22, 2021</last_update_submitted>
  <last_update_submitted_qc>August 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Xiuqin Wang</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448197
org study id: 2019-SR-484
nct id: NCT04448197
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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 .
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.
observational model: Other
time perspective: Prospective
measure: Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at Month 1
time frame: Baseline and month 1
description: 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)
measure: Change from Baseline in the total score of the 17-item Hamilton Depression Scale (HAMD-17) at Month 1
time frame: Baseline and month 1
description: 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)
measure: Change in of the ALT，to evaluate the safety of TCM treatment
time frame: Baseline and month 1
description: Alanine aminotransferase, ALT in U/L.
measure: Change in of the AST，to evaluate the safety of TCM treatment
time frame: Baseline and month 1
description: Aspartate aminotransferase, AST in U/L
measure: Change in of the BUN，to evaluate the safety of TCM treatment
time frame: Baseline and month 1
description: Blood urea nitrogen, BUN in mmol/L
measure: Change in of the Scr，to evaluate the safety of TCM treatment
time frame: Baseline and month 1
description: Serum creatinine, Scr in μmol/L
measure: Change in of the Hcy，to evaluate the safety of TCM treatment
time frame: Baseline and month 1
description: Homocysteine, Hcy in μmol/L
measure: Genome-wide association study，in bp，to explore the correlation between insomnia and circadian rhythm of biological clock
time frame: 1 year
description: Illumina HumanHap550-Duo BeadChips was used to perform the whole genome genotyping in deCODE genetics (Reykjavı'k, Iceland)
intervention type: Other
intervention name: Chinese Medicine
description: Dialectical treatment of traditional Chinese medicine according to different constitution
Routine blood test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiuqin Wang, doctor
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Xiuqin Wang
investigator title: Chief physician
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Undecided