<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/NCT03258216</url>
  </required_header>
  <id_info>
    <org_study_id>104-4725B</org_study_id>
    <nct_id>NCT03258216</nct_id>
  </id_info>
  <brief_title>TCM Tongue Diagnosis Indices of UGI Disorders</brief_title>
  <official_title>The Traditional Chinese Medicine (TCM) Tongue Diagnosis Indices of Upper Gastrointestinal (UGI) Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and&#xD;
      extract features reliably to assist the diagnosis of TCM practitioners.This project will&#xD;
      employ the ATDS verified to extract the tongue features of patients with upper&#xD;
      gastrointestinal disorders, such as peptic ulcer, etc. A TCM indices derived through the&#xD;
      non-intrusive tongue diagnosis procedure can provide valuable information for clinical&#xD;
      doctors to analyze the current status of a patient and dynamically schedule a treatment plan,&#xD;
      facilitating early detection and diagnosis of upper gastrointestinal disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upper gastrointestinal disorders are common in clinical practice. Currently, the diagnosis of&#xD;
      peptic ulcer only depends on laboratory exams such as clinical symptoms, blood test, urine&#xD;
      test and feces test. But the result can be only auxiliary exams which don't gain correct&#xD;
      diagnosis on helping assess ulcer severity. As the most suitable diagnosis method,&#xD;
      panendoscopy can directly observe lesions, judge disease severity, carry out a biopsy, test&#xD;
      lesion is benignant or malignant, Helicobacter Pylorus infection or not, the degree of&#xD;
      inflammation, etc. But panendoscopy belongs to invasive test. If we can observe tongue&#xD;
      characteristics of patients with upper gastrointestinal diseases through scientific tongue&#xD;
      diagnosis, physical discomfort caused by the test will be significantly reduced.&#xD;
&#xD;
      Based on clinical observational study, this project will employ the Automatic Tongue&#xD;
      Diagnosis System (ATDS) developed. The ATDS was developed to capture tongue images and&#xD;
      extract features reliably to assist the diagnosis of TCM practitioners demonstrates the steps&#xD;
      in the three major functions, i.e., image capturing and color calibration, tongues area&#xD;
      segmentation, and tongue feature extraction, included in the ATDS.&#xD;
&#xD;
      Variations in background lighting may change the color and brightness of the acquired images,&#xD;
      greatly affecting consistency and stability of the extracted tongue features. The ATDS&#xD;
      developed can automatically correct lighting and color deviation caused by the change of&#xD;
      background lighting with a color bar attached in the ATDS. The color bar placed beside the&#xD;
      patient is used for color calibration to make sure the image quality is consistent even taken&#xD;
      at different circumstances. Tongue images are analyzed by first isolating the tongue region&#xD;
      within an image to eliminate irrelevant lower facial portions and background surrounding the&#xD;
      tongue, thereby facilitating feature identification and extraction; and then extracting the&#xD;
      tongue features by employing criteria such as the aspect ratio, color composition, location,&#xD;
      shape, and color distribution of the tongue, as well as the quantity of neighboring pixels.&#xD;
      Features including tongue color, tongue fissure, fur color, fur thickness, ecchymosis, tooth&#xD;
      mark, red dot, saliva, and tongue shape are extracted to further generate detailed&#xD;
      information regarding length, area, moisture, and number of fissures, marks, and dots to be&#xD;
      employed in tongue diagnosis. Nine primary tongue features, including tongue color (slightly&#xD;
      white, slightly red, red, dark red, dark purple), fur color (white, yellow, dye), fur&#xD;
      thickness (none, thin, thick), saliva (none, little, normal, excessive), tongue shape (thin&#xD;
      and small, moderate, fat and large), tongue fissure, red dot, ecchymosis, and tooth marks&#xD;
      (the last four features are divided into categories of none, mild, moderate, and severe), are&#xD;
      selected for tongue diagnosis.&#xD;
&#xD;
      This project will employ the ATDS verified to extract the tongue features of patients with&#xD;
      upper gastrointestinal disorders. Through statistically analysis of the data collected and&#xD;
      cross-referencing the existing indices of western medicine, we aim to derive meaningful TCM&#xD;
      indices from tongue diagnosis of upper gastrointestinal diseases, such as peptic ulcer, etc.&#xD;
      A TCM indices derived through the non-intrusive tongue diagnosis procedure can provide&#xD;
      valuable information for clinical doctors to analyze the current status of a patient and&#xD;
      dynamically schedule a treatment plan, facilitating early detection and diagnosis of upper&#xD;
      gastrointestinal disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tongue features</measure>
    <time_frame>5-10 mins</time_frame>
    <description>diagnosed by the Automatic Tongue Diagnosis System (ATDS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Panendoscopy report</measure>
    <time_frame>20-30 mins</time_frame>
    <description>diagnosed upper GI disorders by panendoscopy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">134</enrollment>
  <condition>Upper Gastrointestinal Disorders</condition>
  <arm_group>
    <arm_group_label>peptic ulcer</arm_group_label>
    <description>patients who had upper GI symptoms and diagnosed as peptic ulcer by panendoscopy, followed tongue images by Automatic Tongue Diagnosis System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy</arm_group_label>
    <description>patients who had no past history or systemic disease, diagnosed as UGI negative finding by panendoscopy, followed tongue images by Automatic Tongue Diagnosis System</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>panendoscopy</intervention_name>
    <description>panendoscopy</description>
    <arm_group_label>healthy</arm_group_label>
    <arm_group_label>peptic ulcer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>tongue image</intervention_name>
    <description>capture tongue images by Automatic Tongue Diagnosis System</description>
    <arm_group_label>healthy</arm_group_label>
    <arm_group_label>peptic ulcer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with upper gastrointestinal disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with upper gastrointestinal disorders&#xD;
&#xD;
          -  Both males and females above 20 years old were included&#xD;
&#xD;
          -  Patients who had signed Institutional Review Board (IRB) agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had not signed IRB agreement&#xD;
&#xD;
          -  Patients who had hypertension, diabetes, hepatitis, or other systemic diseases&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient with acute infection&#xD;
&#xD;
          -  Cognitive impaired, for example, cancer metastasis to brain or dementia&#xD;
&#xD;
          -  Risk of temporomandibular joint dislocation&#xD;
&#xD;
          -  Patients unable to protrude the tongue stably&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yu-chiang hung, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Lo LC, Cheng TL, Chiang JY, Damdinsuren N. Breast cancer index: a perspective on tongue diagnosis in traditional chinese medicine. J Tradit Complement Med. 2013 Jul;3(3):194-203. doi: 10.4103/2225-4110.114901.</citation>
    <PMID>24716178</PMID>
  </reference>
  <reference>
    <citation>Lo LC, Chiang JY, Cheng TL, Shieh PS. Visual agreement analyses of traditional chinese medicine: a multiple-dimensional scaling approach. Evid Based Complement Alternat Med. 2012;2012:516473. doi: 10.1155/2012/516473. Epub 2012 Sep 17.</citation>
    <PMID>23024693</PMID>
  </reference>
  <reference>
    <citation>Kim J, Son J, Jang S, Nam DH, Han G, Yeo I, Ko SJ, Park JW, Ryu B, Kim J. Availability of tongue diagnosis system for assessing tongue coating thickness in patients with functional dyspepsia. Evid Based Complement Alternat Med. 2013;2013:348272. doi: 10.1155/2013/348272. Epub 2013 Sep 15.</citation>
    <PMID>24159343</PMID>
  </reference>
  <reference>
    <citation>Chiu CC. A novel approach based on computerized image analysis for traditional Chinese medical diagnosis of the tongue. Comput Methods Programs Biomed. 2000 Feb;61(2):77-89. doi: 10.1016/s0169-2607(99)00031-0.</citation>
    <PMID>10661393</PMID>
  </reference>
  <reference>
    <citation>Lee TC, Lo LC, Wu FC. Traditional Chinese Medicine for Metabolic Syndrome via TCM Pattern Differentiation: Tongue Diagnosis for Predictor. Evid Based Complement Alternat Med. 2016;2016:1971295. doi: 10.1155/2016/1971295. Epub 2016 May 25.</citation>
    <PMID>27313640</PMID>
  </reference>
  <reference>
    <citation>Kim J, Han G, Ko SJ, Nam DH, Park JW, Ryu B, Kim J. Tongue diagnosis system for quantitative assessment of tongue coating in patients with functional dyspepsia: a clinical trial. J Ethnopharmacol. 2014 Aug 8;155(1):709-13. doi: 10.1016/j.jep.2014.06.010. Epub 2014 Jun 13.</citation>
    <PMID>24933221</PMID>
  </reference>
  <reference>
    <citation>Lo LC, Chen CY, Chiang JY, Cheng TL, Lin HJ, Chang HH. Tongue diagnosis of traditional Chinese medicine for rheumatoid arthritis. Afr J Tradit Complement Altern Med. 2013 Aug 12;10(5):360-9. doi: 10.4314/ajtcam.v10i5.24. eCollection 2013.</citation>
    <PMID>24311851</PMID>
  </reference>
  <reference>
    <citation>Lo LC, Chen YF, Chen WJ, Cheng TL, Chiang JY. The Study on the Agreement between Automatic Tongue Diagnosis System and Traditional Chinese Medicine Practitioners. Evid Based Complement Alternat Med. 2012;2012:505063. doi: 10.1155/2012/505063. Epub 2012 Aug 8.</citation>
    <PMID>22924055</PMID>
  </reference>
  <reference>
    <citation>Hu J, Han S, Chen Y, Ji Z. Variations of Tongue Coating Microbiota in Patients with Gastric Cancer. Biomed Res Int. 2015;2015:173729. doi: 10.1155/2015/173729. Epub 2015 Sep 17.</citation>
    <PMID>26457297</PMID>
  </reference>
  <reference>
    <citation>Jung CJ, Jeon YJ, Kim JY, Kim KH. Review on the current trends in tongue diagnosis systems. Integr Med Res. 2012 Dec;1(1):13-20. doi: 10.1016/j.imr.2012.09.001. Epub 2012 Oct 5.</citation>
    <PMID>28664042</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>September 17, 2020</last_update_submitted>
  <last_update_submitted_qc>September 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>hung yu chiang</investigator_full_name>
    <investigator_title>Director of Chinese Medicine department</investigator_title>
  </responsible_party>
  <keyword>Upper gastrointestinal disorders</keyword>
  <keyword>Automatic tongue diagnosis system</keyword>
  <keyword>Panendoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03258216
org study id: 104-4725B
nct id: NCT03258216
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The Automatic Tongue Diagnosis System (ATDS) was developed to capture tongue images and
      extract features reliably to assist the diagnosis of TCM practitioners.This project will
      employ the ATDS verified to extract the tongue features of patients with upper
      gastrointestinal disorders, such as peptic ulcer, etc. A TCM indices derived through the
      non-intrusive tongue diagnosis procedure can provide valuable information for clinical
      doctors to analyze the current status of a patient and dynamically schedule a treatment plan,
      facilitating early detection and diagnosis of upper gastrointestinal disorders.
Upper gastrointestinal disorders are common in clinical practice. Currently, the diagnosis of
      peptic ulcer only depends on laboratory exams such as clinical symptoms, blood test, urine
      test and feces test. But the result can be only auxiliary exams which don't gain correct
      diagnosis on helping assess ulcer severity. As the most suitable diagnosis method,
      panendoscopy can directly observe lesions, judge disease severity, carry out a biopsy, test
      lesion is benignant or malignant, Helicobacter Pylorus infection or not, the degree of
      inflammation, etc. But panendoscopy belongs to invasive test. If we can observe tongue
      characteristics of patients with upper gastrointestinal diseases through scientific tongue
      diagnosis, physical discomfort caused by the test will be significantly reduced.

      Based on clinical observational study, this project will employ the Automatic Tongue
      Diagnosis System (ATDS) developed. The ATDS was developed to capture tongue images and
      extract features reliably to assist the diagnosis of TCM practitioners demonstrates the steps
      in the three major functions, i.e., image capturing and color calibration, tongues area
      segmentation, and tongue feature extraction, included in the ATDS.

      Variations in background lighting may change the color and brightness of the acquired images,
      greatly affecting consistency and stability of the extracted tongue features. The ATDS
      developed can automatically correct lighting and color deviation caused by the change of
      background lighting with a color bar attached in the ATDS. The color bar placed beside the
      patient is used for color calibration to make sure the image quality is consistent even taken
      at different circumstances. Tongue images are analyzed by first isolating the tongue region
      within an image to eliminate irrelevant lower facial portions and background surrounding the
      tongue, thereby facilitating feature identification and extraction; and then extracting the
      tongue features by employing criteria such as the aspect ratio, color composition, location,
      shape, and color distribution of the tongue, as well as the quantity of neighboring pixels.
      Features including tongue color, tongue fissure, fur color, fur thickness, ecchymosis, tooth
      mark, red dot, saliva, and tongue shape are extracted to further generate detailed
      information regarding length, area, moisture, and number of fissures, marks, and dots to be
      employed in tongue diagnosis. Nine primary tongue features, including tongue color (slightly
      white, slightly red, red, dark red, dark purple), fur color (white, yellow, dye), fur
      thickness (none, thin, thick), saliva (none, little, normal, excessive), tongue shape (thin
      and small, moderate, fat and large), tongue fissure, red dot, ecchymosis, and tooth marks
      (the last four features are divided into categories of none, mild, moderate, and severe), are
      selected for tongue diagnosis.

      This project will employ the ATDS verified to extract the tongue features of patients with
      upper gastrointestinal disorders. Through statistically analysis of the data collected and
      cross-referencing the existing indices of western medicine, we aim to derive meaningful TCM
      indices from tongue diagnosis of upper gastrointestinal diseases, such as peptic ulcer, etc.
      A TCM indices derived through the non-intrusive tongue diagnosis procedure can provide
      valuable information for clinical doctors to analyze the current status of a patient and
      dynamically schedule a treatment plan, facilitating early detection and diagnosis of upper
      gastrointestinal disorders.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Tongue features
time frame: 5-10 mins
description: diagnosed by the Automatic Tongue Diagnosis System (ATDS)
measure: Panendoscopy report
time frame: 20-30 mins
description: diagnosed upper GI disorders by panendoscopy
arm group label: peptic ulcer
description: patients who had upper GI symptoms and diagnosed as peptic ulcer by panendoscopy, followed tongue images by Automatic Tongue Diagnosis System
arm group label: healthy
description: patients who had no past history or systemic disease, diagnosed as UGI negative finding by panendoscopy, followed tongue images by Automatic Tongue Diagnosis System
intervention type: Diagnostic Test
intervention name: panendoscopy
description: panendoscopy
arm group label: healthy
arm group label: peptic ulcer
intervention type: Diagnostic Test
intervention name: tongue image
description: capture tongue images by Automatic Tongue Diagnosis System
arm group label: healthy
arm group label: peptic ulcer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: yu-chiang hung, Ph.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
citation: Lo LC, Cheng TL, Chiang JY, Damdinsuren N. Breast cancer index: a perspective on tongue diagnosis in traditional chinese medicine. J Tradit Complement Med. 2013 Jul;3(3):194-203. doi: 10.4103/2225-4110.114901.
PMID: 24716178
citation: Lo LC, Chiang JY, Cheng TL, Shieh PS. Visual agreement analyses of traditional chinese medicine: a multiple-dimensional scaling approach. Evid Based Complement Alternat Med. 2012;2012:516473. doi: 10.1155/2012/516473. Epub 2012 Sep 17.
PMID: 23024693
citation: Kim J, Son J, Jang S, Nam DH, Han G, Yeo I, Ko SJ, Park JW, Ryu B, Kim J. Availability of tongue diagnosis system for assessing tongue coating thickness in patients with functional dyspepsia. Evid Based Complement Alternat Med. 2013;2013:348272. doi: 10.1155/2013/348272. Epub 2013 Sep 15.
PMID: 24159343
citation: Chiu CC. A novel approach based on computerized image analysis for traditional Chinese medical diagnosis of the tongue. Comput Methods Programs Biomed. 2000 Feb;61(2):77-89. doi: 10.1016/s0169-2607(99)00031-0.
PMID: 10661393
citation: Lee TC, Lo LC, Wu FC. Traditional Chinese Medicine for Metabolic Syndrome via TCM Pattern Differentiation: Tongue Diagnosis for Predictor. Evid Based Complement Alternat Med. 2016;2016:1971295. doi: 10.1155/2016/1971295. Epub 2016 May 25.
PMID: 27313640
citation: Kim J, Han G, Ko SJ, Nam DH, Park JW, Ryu B, Kim J. Tongue diagnosis system for quantitative assessment of tongue coating in patients with functional dyspepsia: a clinical trial. J Ethnopharmacol. 2014 Aug 8;155(1):709-13. doi: 10.1016/j.jep.2014.06.010. Epub 2014 Jun 13.
PMID: 24933221
citation: Lo LC, Chen CY, Chiang JY, Cheng TL, Lin HJ, Chang HH. Tongue diagnosis of traditional Chinese medicine for rheumatoid arthritis. Afr J Tradit Complement Altern Med. 2013 Aug 12;10(5):360-9. doi: 10.4314/ajtcam.v10i5.24. eCollection 2013.
PMID: 24311851
citation: Lo LC, Chen YF, Chen WJ, Cheng TL, Chiang JY. The Study on the Agreement between Automatic Tongue Diagnosis System and Traditional Chinese Medicine Practitioners. Evid Based Complement Alternat Med. 2012;2012:505063. doi: 10.1155/2012/505063. Epub 2012 Aug 8.
PMID: 22924055
citation: Hu J, Han S, Chen Y, Ji Z. Variations of Tongue Coating Microbiota in Patients with Gastric Cancer. Biomed Res Int. 2015;2015:173729. doi: 10.1155/2015/173729. Epub 2015 Sep 17.
PMID: 26457297
citation: Jung CJ, Jeon YJ, Kim JY, Kim KH. Review on the current trends in tongue diagnosis systems. Integr Med Res. 2012 Dec;1(1):13-20. doi: 10.1016/j.imr.2012.09.001. Epub 2012 Oct 5.
PMID: 28664042
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: hung yu chiang
investigator title: Director of Chinese Medicine department
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
sharing ipd: No