<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/NCT02996786</url>
  </required_header>
  <id_info>
    <org_study_id>MOST 106-2410-H-037-007-MY3</org_study_id>
    <nct_id>NCT02996786</nct_id>
  </id_info>
  <brief_title>Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners</brief_title>
  <official_title>Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood&#xD;
      biochemical parameters in male recreational runners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Male recreational runners would be recruited by community websites or email. After&#xD;
           completely introducing the study, the participants would be requested to sign informed&#xD;
           consent.&#xD;
&#xD;
        2. The participants would perform maximal oxygen consumption test prior to the&#xD;
           supplementation. The participants would be supplemented with either Danggui Buxue Tang&#xD;
           or placebo for a week before performing the 13-km run. A total of 4 times blood&#xD;
           collection (before supplementation, immediate after running, 1 day and 3 days after&#xD;
           running) would be performed for evaluating the effect of Danggui Buxue Tang on blood&#xD;
           biochemical parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hematological parameters</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Complete blood counts and serum haptoglobin and erythropoietin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron status</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Serum iron, ferritin, transferrin and hepcidin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory response</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Running time</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The completion time for a 13-km run</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Sports Anemia</condition>
  <condition>Inflammation</condition>
  <condition>Oxidative Stress</condition>
  <condition>Iron Deficiency</condition>
  <condition>Hemolysis</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Danggui Buxue Tang group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Danggui Buxue Tang</intervention_name>
    <description>Danggui Buxue Tang purchased from Kaiser Pharmaceutical</description>
    <arm_group_label>Danggui Buxue Tang group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Consisting of corn starch and carboxymethyl cellulose</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participants should have the experience finishing 10-km run but without the&#xD;
             experience of attending a marathon run.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants suffering from anemia (Hb &lt;13 g/dL), taking usual supplements,&#xD;
             medication, alcohol or not feeling comfortable.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Medical University</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Hemolysis</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/NCT02996786
org study id: MOST 106-2410-H-037-007-MY3
nct id: NCT02996786
lead sponsor: 
has dmc: No
The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood
      biochemical parameters in male recreational runners.
1. Male recreational runners would be recruited by community websites or email. After
           completely introducing the study, the participants would be requested to sign informed
           consent.

        2. The participants would perform maximal oxygen consumption test prior to the
           supplementation. The participants would be supplemented with either Danggui Buxue Tang
           or placebo for a week before performing the 13-km run. A total of 4 times blood
           collection (before supplementation, immediate after running, 1 day and 3 days after
           running) would be performed for evaluating the effect of Danggui Buxue Tang on blood
           biochemical parameters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Hematological parameters
time frame: Through study completion, an average of 1 year
description: Complete blood counts and serum haptoglobin and erythropoietin
measure: Iron status
time frame: Through study completion, an average of 1 year
description: Serum iron, ferritin, transferrin and hepcidin
measure: Oxidative stress
time frame: Through study completion, an average of 1 year
description: Thiobarbituric acid reactive substances, superoxide dismutase, catalase, and glutathione peroxidase
measure: Inflammatory response
time frame: Through study completion, an average of 1 year
description: High-sensitivity c-reactive protein, Tumor necrosis factor-alpha, and interleukin-6
measure: Running time
time frame: Through study completion, an average of 1 year
description: The completion time for a 13-km run
arm group label: Danggui Buxue Tang group
arm group type: Experimental
description: Danggui Buxue Tang group receive orally supplementation of 7.5 g/day of Danggui Buxue Tang for 10 days
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo group receive orally supplementation of 7.5 g/day of placebo for 10 days
intervention type: Dietary Supplement
intervention name: Danggui Buxue Tang
description: Danggui Buxue Tang purchased from Kaiser Pharmaceutical
arm group label: Danggui Buxue Tang group
intervention type: Other
intervention name: Placebo
description: Consisting of corn starch and carboxymethyl cellulose
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Iron Deficiencies
mesh term: Inflammation
mesh term: Hemolysis
sharing ipd: No