<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/NCT03790033</url>
  </required_header>
  <id_info>
    <org_study_id>ISEE_2018_UCHA</org_study_id>
    <nct_id>NCT03790033</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial</brief_title>
  <official_title>Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gachon University Gil Oriental Medical Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Semyung University Affiliated Oriental Medical Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sangji University Oriental Medical Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gachon University Gil Oriental Medical Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold&#xD;
      Hypersensitivity in the Hands and Feet&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">September 14, 2019</completion_date>
  <primary_completion_date type="Actual">August 14, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in visual analogue scale(VAS)</measure>
    <time_frame>At baseline, week 4, 8, 12</time_frame>
    <description>The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in body temperature</measure>
    <time_frame>At baseline, week 4, 8, 12</time_frame>
    <description>Changes from baseline in body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in WHO Quality of Life-BREF</measure>
    <time_frame>At baseline, week 4, 8, 12</time_frame>
    <description>It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in blood pressure</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>assess for monitoring patient safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Pulse rate</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>assess for monitoring patient safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of AST</measure>
    <time_frame>At screening visit, week 8</time_frame>
    <description>liver function test for monitoring patient safety(IU/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of ALT</measure>
    <time_frame>Kidney function test for monitoring patient safety(mmol/L)</time_frame>
    <description>liver function test for monitoring patient safety(IU/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of r-GTP</measure>
    <time_frame>Kidney function test for monitoring patient safety(mmol/L)</time_frame>
    <description>liver function test for monitoring patient safety(IU/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of BUN</measure>
    <time_frame>Kidney function test for monitoring patient safety(mmol/L)</time_frame>
    <description>Kidney function test for monitoring patient safety(mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of Cr</measure>
    <time_frame>Kidney function test for monitoring patient safety(mmol/L)</time_frame>
    <description>Kidney function test for monitoring patient safety(mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>At week 4, 8, 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pattern Identification Questionnaire</measure>
    <time_frame>At screening visit</time_frame>
    <description>This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Cold Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>UCHA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ucha-Shinki-Hwan</intervention_name>
    <description>Product name : Bosinji Granule Manufacturer : Tsumura &amp; Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g)&#xD;
Bosinji extract is composed of following proportion of ingredient&#xD;
Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g</description>
    <arm_group_label>UCHA group</arm_group_label>
    <other_name>Bosinji</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo granule</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects aged 19 to 59 years have a complaint of CHHF.&#xD;
&#xD;
          -  Patients must include at least one or more of the following symptoms:&#xD;
&#xD;
          -  Those who have the symptoms of CHH in normal temperature which most individuals feel&#xD;
             no cold;&#xD;
&#xD;
          -  Those who have the symptoms of extremely cold hands in cold temperature exposure;&#xD;
&#xD;
          -  Those who are on the return to a warmer environment, the symptoms of cold hands is not&#xD;
             completely rewarmed;&#xD;
&#xD;
          -  Those who have 4 cm or greater of VAS CHH score;&#xD;
&#xD;
          -  A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher&#xD;
             than 0.3℃;&#xD;
&#xD;
          -  Those who can comply with all study-related procedures, medications, and evaluations;&#xD;
&#xD;
          -  Given a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;&#xD;
&#xD;
          -  Those who have one or more finger gangrene or ulceration;&#xD;
&#xD;
          -  Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;&#xD;
&#xD;
          -  Those who are diagnosed by autoimmune disease or have a positive ANA test result;&#xD;
&#xD;
          -  Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and&#xD;
             Phalen's tests;&#xD;
&#xD;
          -  Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;&#xD;
&#xD;
          -  Those who are diagnosed with diabetes;&#xD;
&#xD;
          -  Those who are currently medicated to drugs that may affect to CHH symptoms, such as&#xD;
             anticoagulants etc;&#xD;
&#xD;
          -  Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100&#xD;
             IU/L) or kidney dysfunction (Cr 2.0mg/dL);&#xD;
&#xD;
          -  Those who do not (cannot) abide by treatment and follow up due to the mental illness&#xD;
             such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious&#xD;
             mental illness;&#xD;
&#xD;
          -  Those who are Diagnosed with moderate anemia and hematologic disorders (adult&#xD;
             non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less&#xD;
             than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic&#xD;
             blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100&#xD;
             mmHg based on average value of at least 2 measurements;&#xD;
&#xD;
          -  Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart&#xD;
             diseases, such as, ischemic heart disease and so on;&#xD;
&#xD;
          -  Those who are addicted to alcohol or drugs;&#xD;
&#xD;
          -  Those who are pregnant (positive urine-HCG) or lactating or have the chances of&#xD;
             pregnancy;&#xD;
&#xD;
          -  Those who are diagnosed with malignant tumor&#xD;
&#xD;
          -  Those who are currently participated in other clinical trials;&#xD;
&#xD;
          -  Those who are able to understand and speak Korean;&#xD;
&#xD;
          -  Those who are judged to be inappropriate for the clinical study by the researchers.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chan Yong Jun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Oriental Medicine Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyung Hee University medical center at Gangdong</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gachon University Gil Oriental Medical Hospital</investigator_affiliation>
    <investigator_full_name>Chan-Yong Jeon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cold Hypersensitivity</keyword>
  <keyword>Korean medicine</keyword>
  <keyword>Ucha-Shinki-Hwan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cryopyrin-Associated Periodic Syndromes</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>not decided</ipd_description>
  </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/NCT03790033
org study id: ISEE_2018_UCHA
nct id: NCT03790033
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold
      Hypersensitivity in the Hands and Feet
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Changes from baseline in visual analogue scale(VAS)
time frame: At baseline, week 4, 8, 12
description: The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
measure: Changes from baseline in body temperature
time frame: At baseline, week 4, 8, 12
description: Changes from baseline in body temperature
measure: Changes from baseline in WHO Quality of Life-BREF
time frame: At baseline, week 4, 8, 12
description: It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
measure: Changes from baseline in blood pressure
time frame: up to 12 weeks
description: assess for monitoring patient safety
measure: Changes from baseline in Pulse rate
time frame: up to 12 weeks
description: assess for monitoring patient safety
measure: Levels of AST
time frame: At screening visit, week 8
description: liver function test for monitoring patient safety(IU/L)
measure: Levels of ALT
time frame: Kidney function test for monitoring patient safety(mmol/L)
description: liver function test for monitoring patient safety(IU/L)
measure: Levels of r-GTP
time frame: Kidney function test for monitoring patient safety(mmol/L)
description: liver function test for monitoring patient safety(IU/L)
measure: Levels of BUN
time frame: Kidney function test for monitoring patient safety(mmol/L)
description: Kidney function test for monitoring patient safety(mmol/L)
measure: Levels of Cr
time frame: Kidney function test for monitoring patient safety(mmol/L)
description: Kidney function test for monitoring patient safety(mmol/L)
measure: Adverse event
time frame: At week 4, 8, 12
measure: Pattern Identification Questionnaire
time frame: At screening visit
description: This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool.
arm group label: UCHA group
arm group type: Experimental
description: 2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company
arm group label: Placebo group
arm group type: Placebo Comparator
description: 2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan
intervention type: Drug
intervention name: Ucha-Shinki-Hwan
description: Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g)
Bosinji extract is composed of following proportion of ingredient
Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g
arm group label: UCHA group
other name: Bosinji
intervention type: Drug
intervention name: Placebo
description: placebo granule
arm group label: Placebo group
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 59 Years
healthy volunteers: No
last name: Chan Yong Jun
role: Principal Investigator
affiliation: Gachon University Gil Oriental Medicine Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gachon University Gil Oriental Medical Hospital
investigator full name: Chan-Yong Jeon
investigator title: Principal Investigator
mesh term: Cryopyrin-Associated Periodic Syndromes
mesh term: Hypersensitivity
sharing ipd: Undecided
ipd description: not decided