<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/NCT02191020</url>
  </required_header>
  <id_info>
    <org_study_id>XijingH-PF-20120909</org_study_id>
    <nct_id>NCT02191020</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis</brief_title>
  <official_title>Multi-center, Randomized, Double Blind, Placebo Parallel-Controlled Study of the Efficacy and Safety of Total Glucosides of Paeony Combined With Acitretin Capsules to Treat Psoriasis Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <brief_summary>
    <textblock>
      This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial.&#xD;
      Patients with psoriasis vulgaris were randomly divided into the experiment group （treated&#xD;
      with TGP combined with acitretin capsules) and control group （treated with placebo combined&#xD;
      with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were&#xD;
      evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of&#xD;
      treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe&#xD;
      and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</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>Reduction in Psoriasis Area and Severity Index</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P&lt;0.05).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of elevated Alanine aminotransferase</measure>
    <time_frame>week 0 and week12</time_frame>
    <description>After 12 weeks treatment, relative to baseline,the incidence of elevated Alanine aminotransferase (ALT) was 6.8% in the experiment group and 22.2% in the control group (P&lt;0.05).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Total glucosides of paeony &amp; Acitretin Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acitretin Capsules</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Total glucosides of paeony &amp; Acitretin Capsules</intervention_name>
    <arm_group_label>Total glucosides of paeony &amp; Acitretin Capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acitretin Capsules</intervention_name>
    <arm_group_label>Acitretin Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Meet the following conditions&#xD;
&#xD;
          1. Diagnosed according to Classification criteria for Psoriasis vulgaris;&#xD;
&#xD;
          2. Patients aged 18 to 65 years (to the date of screening);&#xD;
&#xD;
          3. PASI grade&gt;7point&lt;20 point;&#xD;
&#xD;
          4. Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or&#xD;
             Tretinoin cream、Phototherapy nearly one months before enrolled.&#xD;
&#xD;
          5. Understanding the whole process of the study, voluntary participation and signed the&#xD;
             informed consent;&#xD;
&#xD;
          6. Patient compliance is good, can guarantee in course of observation.&#xD;
&#xD;
        Exclusion Criteria:One of the following is not included in this study:&#xD;
&#xD;
          1. Pregnant women, ready to pregnant or lactating women;&#xD;
&#xD;
          2. Known to root of herbaceous peony total glycosides (TGP) drug allergy;&#xD;
&#xD;
          3. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions&#xD;
             and the history&#xD;
&#xD;
          4. Patients is liver function abnormal persons (ALT above the center laboratory normal&#xD;
             limit) or hepatitis b patient grain carriers;&#xD;
&#xD;
          5. Need insulin control of diabetes; High blood pressure did not get good controller ;&#xD;
&#xD;
          6. Patients with white blood cells &lt;4.0 × 109 / L, or a definite anemia (hemoglobin less&#xD;
             than 100g / L), or platelets &lt;100 × 109 / L, or other blood disease;&#xD;
&#xD;
          7. Patients with chronic diarrhea, or peptic ulcer nearly 1 year;&#xD;
&#xD;
          8. Patients suffering from malignant tumor;&#xD;
&#xD;
          9. Patients suffering from acute and chronic infectious diseases;&#xD;
&#xD;
         10. Mental disorders, history of alcohol abuse, drug or other substance abuse; 11. Other&#xD;
             cases which researchers believe that can not enroll.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xijing Hospitial</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>January 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>xjpfW</investigator_full_name>
    <investigator_title>Chief in Department of Dermatology</investigator_title>
  </responsible_party>
  <keyword>Total Glucosides of Paeony(TGP)</keyword>
  <keyword>Acitretin Capsules</keyword>
  <keyword>Psoriasis Vulgaris</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acitretin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02191020
org study id: XijingH-PF-20120909
nct id: NCT02191020
lead sponsor: 
collaborator: 
collaborator: 
This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial.
      Patients with psoriasis vulgaris were randomly divided into the experiment group （treated
      with TGP combined with acitretin capsules) and control group （treated with placebo combined
      with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were
      evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of
      treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe
      and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduction in Psoriasis Area and Severity Index
time frame: week 0 and week 12
description: After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P<0.05).
measure: incidence of elevated Alanine aminotransferase
time frame: week 0 and week12
description: After 12 weeks treatment, relative to baseline,the incidence of elevated Alanine aminotransferase (ALT) was 6.8% in the experiment group and 22.2% in the control group (P<0.05).
arm group label: Total glucosides of paeony & Acitretin Capsules
arm group type: Experimental
description: During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d
arm group label: Acitretin Capsules
arm group type: Active Comparator
description: 20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.
intervention type: Drug
intervention name: Total glucosides of paeony & Acitretin Capsules
arm group label: Total glucosides of paeony & Acitretin Capsules
intervention type: Drug
intervention name: Acitretin Capsules
arm group label: Acitretin Capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: xjpfW
investigator title: Chief in Department of Dermatology
mesh term: Psoriasis
mesh term: Acitretin