<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/NCT03258437</url>
  </required_header>
  <id_info>
    <org_study_id>DA-9401-SM</org_study_id>
    <nct_id>NCT03258437</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DA-9401 on Improvement of Sperm Motility</brief_title>
  <official_title>A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. and Cuscuta Chinensis Lam. Extract Mixtures (DA-9401) on Improvement of Sperm Motility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korean Society for Sexual Medicine and Andrology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korean Society for Sexual Medicine and Andrology</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study was conducted to investigate the effects of daily supplementation of Allium cepa&#xD;
      L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human&#xD;
      trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam.&#xD;
      Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2016</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Sperm motility</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of sperm profile were assessed before and after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of Sperm count</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of Sperm count(X10^6(M)/ml) profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Ejaculated volume</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of Ejaculated volume(ml) profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Sperm morphology</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of Sperm morphology(%) profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Ejaculated pH</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of Ejaculated pH profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of hormone(Total testosterone, FSH, LH)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of hormone{Total testosterone(ng/ml), FSH and LH(mlU/ml)} profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of IIEF(International Index of Erectile Function)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of questionnaire profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of MFS(Multidimensional Fatigue Scale)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of questionnaire profile were assessed before and after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Spermatocele</condition>
  <arm_group>
    <arm_group_label>DA-9401</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>capsules (4cap/d, 2.16 g/d) for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>DA-9401</intervention_name>
    <arm_group_label>DA-9401</arm_group_label>
    <other_name>capsules (4cap/d, 2.16 g/d) for 12 weeks.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-55 years&#xD;
&#xD;
          -  sperm motility 40~69%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Participation in any other clinical trials within past 1 months&#xD;
&#xD;
          -  intense constipation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chonbuk National University Hospital of urology</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>560-822</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 5, 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>March 18, 2018</last_update_submitted>
  <last_update_submitted_qc>March 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korean Society for Sexual Medicine and Andrology</investigator_affiliation>
    <investigator_full_name>Park Jong Kwan</investigator_full_name>
    <investigator_title>Principal Investigator, Chonbuk National University Hospital, Urology</investigator_title>
  </responsible_party>
  <keyword>sperm motility, Clinical Trial , DA-9401</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spermatocele</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/NCT03258437
org study id: DA-9401-SM
nct id: NCT03258437
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to investigate the effects of daily supplementation of Allium cepa
      L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.
This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human
      trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam.
      Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of Sperm motility
time frame: 12 weeks
description: Changes of sperm profile were assessed before and after the intervention
measure: Changes of Sperm count
time frame: 12 weeks
description: Changes of Sperm count(X10^6(M)/ml) profile were assessed before and after the intervention
measure: Changes of Ejaculated volume
time frame: 12 weeks
description: Changes of Ejaculated volume(ml) profile were assessed before and after the intervention
measure: Changes of Sperm morphology
time frame: 12 weeks
description: Changes of Sperm morphology(%) profile were assessed before and after the intervention
measure: Changes of Ejaculated pH
time frame: 12 weeks
description: Changes of Ejaculated pH profile were assessed before and after the intervention
measure: Changes of hormone(Total testosterone, FSH, LH)
time frame: 12 weeks
description: Changes of hormone{Total testosterone(ng/ml), FSH and LH(mlU/ml)} profile were assessed before and after the intervention
measure: Changes of IIEF(International Index of Erectile Function)
time frame: 12 weeks
description: Changes of questionnaire profile were assessed before and after the intervention
measure: Changes of MFS(Multidimensional Fatigue Scale)
time frame: 12 weeks
description: Changes of questionnaire profile were assessed before and after the intervention
arm group label: DA-9401
arm group type: Experimental
description: capsules (4cap/d, 2.16 g/d) for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 12 weeks.
intervention type: Dietary Supplement
intervention name: DA-9401
arm group label: DA-9401
other name: capsules (4cap/d, 2.16 g/d) for 12 weeks.
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo for 12 weeks.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korean Society for Sexual Medicine and Andrology
investigator full name: Park Jong Kwan
investigator title: Principal Investigator, Chonbuk National University Hospital, Urology
mesh term: Spermatocele
sharing ipd: Undecided