<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/NCT03290313</url>
  </required_header>
  <id_info>
    <org_study_id>DHZD-SGYY</org_study_id>
    <nct_id>NCT03290313</nct_id>
  </id_info>
  <brief_title>Clinical Trial Scheme of Shu Gan yi Yang Capsule</brief_title>
  <official_title>a Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial of Efficacy and Safety of Shu Gan yi Yang Capsule in the Treatment of Depression Associated With Erectile Dysfunction (Stagnation of Liver qi and Kidney Deficiency)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guizhou Yi Bai Pharmaceutical Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Sixth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing HuiLongGuan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Hospital of Traditional Chinese Medicine</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>
      Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical&#xD;
      Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and&#xD;
      blood stasis caused by functional impotence and mild arterial insufficiency in impotence,&#xD;
      impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness,&#xD;
      soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string.&#xD;
      The choice of depression associated with erectile dysfunction patients, and investigate its&#xD;
      effect.In this study, patients with depression and erectile dysfunction were selected and the&#xD;
      efficacy was investigated&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a placebo-controlled clinical trial, 160 patients with depression and erectile&#xD;
      dysfunction were selected for 8 weeks of observation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Phase 4</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>change of The international index of erectile function (IIEF-5) total score</measure>
    <time_frame>from baseline to endpoint(Week 8)</time_frame>
    <description>Each follow-up according to recent life situation, choose the best option for the 5 question, each item is scored 0-5,the total score of 5-7 divided into severe Erectile dysfunction, 8-11 divided into moderate Erectile dysfunction, 12-21 divided into mild Erectile dysfunction, 22-25 for not suffering from Erectile dysfunction (normal)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of Montgomery Depression Rating Scale(MADRS)total score</measure>
    <time_frame>from baseline to endpoint(Week 8)</time_frame>
    <description>Montgomery Depression Rating Scale includes 10 items, each item is scored 0-6 , extreme depression: MADRS≥35; severe depression: 35&gt; MADRS≥30; moderate depression: 30&gt; MADRS ≥ 22;Mild depression: 22&gt; MADRS ≥ 12; remission: MADRS &lt;12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of total score of Hamilton Anxiety Scale (HAMA)</measure>
    <time_frame>from baseline to endpoint(Week 8)</time_frame>
    <description>Each time the follow-up score was based on the contents of the scale，Each item is scored 0-4(0=Asymptomatic，4=extreme）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of traditional Chinese medicine syndrome integral</measure>
    <time_frame>from baseline to endpoint(Week 8)</time_frame>
    <description>Each time the follow-up score was based on the contents of the scale，Tongue pulse does not score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A change in the effect of individual symptoms</measure>
    <time_frame>from baseline to endpoint(Week 8)</time_frame>
    <description>Changes in each individual item of the scale were collected at each follow-up visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Depression With Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>shu gan yi yang capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 capsules / time, 3 times / day, taking 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>shu gan yi yang capsule capsule simulation agent</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>4 capsules / time, 3 times / day, taking 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>shu gan yi yang capsule</intervention_name>
    <description>Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication</description>
    <arm_group_label>shu gan yi yang capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>shu gan yi yang capsule simulation agent</intervention_name>
    <description>Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication</description>
    <arm_group_label>shu gan yi yang capsule capsule simulation agent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive psychotherapy</intervention_name>
    <description>Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial</description>
    <arm_group_label>shu gan yi yang capsule</arm_group_label>
    <arm_group_label>shu gan yi yang capsule capsule simulation agent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the diagnostic criteria for Western medicine in depression;&#xD;
&#xD;
          2. MADRS score ≥ 12 points and &lt;30 points;&#xD;
&#xD;
          3. Diagnostic criteria for western medicine in line with erectile dysfunction，IIEF&#xD;
             -5≤21points;&#xD;
&#xD;
          4. TCM syndrome differentiation of liver depression and kidney deficiency in accordance&#xD;
             with depression and erectile dysfunction;&#xD;
&#xD;
          5. Male subjects, aged 22-65 years old;&#xD;
&#xD;
          6. Patients who have not been treated with antidepressants or have been treated with&#xD;
             antidepressants for more than 1 months and have reached treatment doses have no need&#xD;
             to adjust their medications and dosages within 2 months;&#xD;
&#xD;
          7. The relationship between patients and sexual partners is stable (at least in the last&#xD;
             6 months);&#xD;
&#xD;
          8. Volunteer to participate in clinical trials, and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A patient with major depressive disorder with psychotic symptoms or suicidal behavior;&#xD;
&#xD;
          2. A genital anatomical abnormality (such as severe penile fibrosis) or other organic&#xD;
             sexual dysfunction with apparent impairment of erection;&#xD;
&#xD;
          3. Erectile dysfunction due to organic disease;&#xD;
&#xD;
          4. Unwilling to stop other patients for depression or erectile dysfunction therapy;&#xD;
&#xD;
          5. A person who has allergies or is sensitive to the ingredients of this test;&#xD;
&#xD;
          6. Combined with severe primary liver and kidney diseases, aspartate aminotransferase ,&#xD;
             Alanine aminotransferase exceeded 1.5 times the normal value, and creatinine exceeded&#xD;
             the normal limit;&#xD;
&#xD;
          7. A patient with severe somatic disease;&#xD;
&#xD;
          8. Patients who have participated in other clinical trials in the past four weeks;&#xD;
&#xD;
          9. A history of drug abuse or alcoholism;&#xD;
&#xD;
         10. The researchers believe that patients who are not eligible for clinical trials are not&#xD;
             eligible for clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>lili zhang</last_name>
    <phone>010-58462584</phone>
    <email>1078002120@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>yingbo zhao</last_name>
    <phone>13517212347</phone>
    <email>61773582@qq.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Jie Zhang,BD</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>erectile dysfunction</keyword>
  <keyword>shu gan yi yang</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_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/NCT03290313
org study id: DHZD-SGYY
nct id: NCT03290313
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shu gan yi yang capsule is made of traditional Chinese medicine Guizhou Yi Bai pharmaceutical
      Limited by Share Ltd, for liver and kidney deficiency and liver and kidney deficiency and
      blood stasis caused by functional impotence and mild arterial insufficiency in impotence,
      impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness,
      soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string.
      The choice of depression associated with erectile dysfunction patients, and investigate its
      effect.In this study, patients with depression and erectile dysfunction were selected and the
      efficacy was investigated
The study is a placebo-controlled clinical trial, 160 patients with depression and erectile
      dysfunction were selected for 8 weeks of observation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: change of The international index of erectile function (IIEF-5) total score
time frame: from baseline to endpoint(Week 8)
description: Each follow-up according to recent life situation, choose the best option for the 5 question, each item is scored 0-5,the total score of 5-7 divided into severe Erectile dysfunction, 8-11 divided into moderate Erectile dysfunction, 12-21 divided into mild Erectile dysfunction, 22-25 for not suffering from Erectile dysfunction (normal)
measure: change of Montgomery Depression Rating Scale(MADRS)total score
time frame: from baseline to endpoint(Week 8)
description: Montgomery Depression Rating Scale includes 10 items, each item is scored 0-6 , extreme depression: MADRS≥35; severe depression: 35> MADRS≥30; moderate depression: 30> MADRS ≥ 22;Mild depression: 22> MADRS ≥ 12; remission: MADRS <12.
measure: The change of total score of Hamilton Anxiety Scale (HAMA)
time frame: from baseline to endpoint(Week 8)
description: Each time the follow-up score was based on the contents of the scale，Each item is scored 0-4(0=Asymptomatic，4=extreme）
measure: Change of traditional Chinese medicine syndrome integral
time frame: from baseline to endpoint(Week 8)
description: Each time the follow-up score was based on the contents of the scale，Tongue pulse does not score
measure: A change in the effect of individual symptoms
time frame: from baseline to endpoint(Week 8)
description: Changes in each individual item of the scale were collected at each follow-up visit
arm group label: shu gan yi yang capsule
arm group type: Experimental
description: 4 capsules / time, 3 times / day, taking 8 weeks
arm group label: shu gan yi yang capsule capsule simulation agent
arm group type: Placebo Comparator
description: 4 capsules / time, 3 times / day, taking 8 weeks
intervention type: Drug
intervention name: shu gan yi yang capsule
description: Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
arm group label: shu gan yi yang capsule
intervention type: Drug
intervention name: shu gan yi yang capsule simulation agent
description: Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
arm group label: shu gan yi yang capsule capsule simulation agent
intervention type: Other
intervention name: Supportive psychotherapy
description: Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
arm group label: shu gan yi yang capsule
arm group label: shu gan yi yang capsule capsule simulation agent
criteria: 
gender: Male
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
last name: lili zhang
phone: 010-58462584
email: 1078002120@qq.com
last name: yingbo zhao
phone: 13517212347
email: 61773582@qq.com
responsible party type: Principal Investigator
investigator affiliation: Beijing Hospital of Traditional Chinese Medicine
investigator full name: Jie Zhang,BD
investigator title: Chief physician
mesh term: Erectile Dysfunction
mesh term: Depression
mesh term: Depressive Disorder