<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/NCT03232554</url>
  </required_header>
  <id_info>
    <org_study_id>IDA201706</org_study_id>
    <nct_id>NCT03232554</nct_id>
  </id_info>
  <brief_title>Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia</brief_title>
  <acronym>BXYMIDA</acronym>
  <official_title>Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to&#xD;
      Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of&#xD;
      participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu&#xD;
      Pills, one third of participanta will receive Ferrous Sulfate，and the another third will&#xD;
      receive Buxue Yimu Pills and Ferrous Sulfate in combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Buxue Yimu Pills, Ferrous Sulfate each Improve anemia, but they do so by different&#xD;
      machanisms. We generally treat patients with uncomplicated Iron Deficiency Anemia with oral&#xD;
      iron due to the ease of administration，and Ferrous Sulfate is one of the most commonly used&#xD;
      drugs.&#xD;
&#xD;
      Buxue Yimu Pills consists of multiple chinses herbs including Angelica&#xD;
      Sinensis，Astragalus，Donkey-Hide Gelatin，Herba Leonuri，Citrus etc., which gains widespread&#xD;
      application in the treatment after women's abortion or operations of uterine cavity. Based on&#xD;
      the characteristics above, we try to explore its clinical application value in Gynecological&#xD;
      Iron-Deficiency Anemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Blood Count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Anemia Related Assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Short Form-36 Health Survey (Sf-36)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Information about health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic Function</measure>
    <time_frame>5 minutes</time_frame>
    <description>Safety Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function</measure>
    <time_frame>5 minutes</time_frame>
    <description>Safety Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Glucose</measure>
    <time_frame>5 minutes</time_frame>
    <description>Safety Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrolyte Semiconductor Junction</measure>
    <time_frame>5 minutes</time_frame>
    <description>Safety Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiogram(ECG)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Safety Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron Metabolism index</measure>
    <time_frame>5 minutes</time_frame>
    <description>Anemia Related Assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Metabonomics Measurement</measure>
    <time_frame>1hour</time_frame>
    <description>Extensive and profound Information</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Iron-Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Buxue Yimu Pills</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Buxue Yimu Pill 12g pill by mouth, twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buxue Yimu Pills &amp;Ferrous Sulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferrous Sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ferrous Sulfate 0.3g tablet by mouth, three times daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buxue Yimu Pills</intervention_name>
    <description>Buxue Yimu Pills 12g pill by mouth, twice daily.</description>
    <arm_group_label>Buxue Yimu Pills</arm_group_label>
    <other_name>Buxue Yimu pellets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buxue Yimu Pills &amp;Ferrous Sulfate</intervention_name>
    <description>Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily</description>
    <arm_group_label>Buxue Yimu Pills &amp;Ferrous Sulfate</arm_group_label>
    <other_name>Buxue Yimu pellets,Iron Sulfate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferrous Sulfate</intervention_name>
    <description>Ferrous Sulfate 0.3g tablet by mouth, three times daily</description>
    <arm_group_label>Ferrous Sulfate</arm_group_label>
    <other_name>Iron Sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is a female between the age of 18 and 50.&#xD;
&#xD;
          -  Subject suffers from mild to moderate anemia with a hemoglobin between 80g/L and 110&#xD;
             g/L.&#xD;
&#xD;
          -  Subject has definite gynecological etiological factors of iron deficiency&#xD;
&#xD;
          -  Subject provides written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject underwent chronic digestive tract inflammation，uncontrolled digestive or&#xD;
             urinary system bleeding.&#xD;
&#xD;
          -  Subject has other complications in addition to gynecological diseases leading to iron&#xD;
             deficiency，such as hemorrhagic diseases of hematologic system，parasitic diseases like&#xD;
             ancylostomiasis，chronic intravascular hemolysis，mechanical hemolysis like prosthetic&#xD;
             valve，renal dysfunction and hemodialysis.&#xD;
&#xD;
          -  Subject is pregnant or lactating.&#xD;
&#xD;
          -  Subject has a severe systemic disease, such as cardiovascular system&#xD;
&#xD;
          -  Subject has a history of malignancy or radiotherapy.&#xD;
&#xD;
          -  Subject has undergone any Iron deficiency anemia treatment including Iron supplements&#xD;
             or blood transfusion within 1month prior to randomization.&#xD;
&#xD;
          -  Subject has mental disorder incapable of elementary cooperations.&#xD;
&#xD;
          -  Subject has participated in other clinical researches of medicine within 1month prior&#xD;
             to randomization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aijun AJ Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei L Li, MD</last_name>
    <phone>139-1198-8831</phone>
    <phone_ext>＋86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei L Li, MD</last_name>
      <phone>13911988831</phone>
      <phone_ext>＋86</phone_ext>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406716/</url>
    <description>Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.</description>
  </link>
  <results_reference>
    <citation>Percy L, Mansour D, Fraser I. Iron deficiency and iron deficiency anaemia in women. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:55-67. doi: 10.1016/j.bpobgyn.2016.09.007. Epub 2016 Oct 1.</citation>
    <PMID>28029503</PMID>
  </results_reference>
  <results_reference>
    <citation>Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.</citation>
    <PMID>28487769</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 8, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>February 10, 2018</last_update_submitted>
  <last_update_submitted_qc>February 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Aijun Sun</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Iron-Deficiency Anemia</keyword>
  <keyword>Buxue Yimu Pills</keyword>
  <keyword>Ferrous Sulfate</keyword>
  <keyword>clinical observations</keyword>
  <keyword>adult women</keyword>
  <keyword>Metabonomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Deficiency Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Network platform, and the website will be attached later.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within 2 months after the trial complete</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03232554/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03232554/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03232554
org study id: IDA201706
nct id: NCT03232554
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to
      Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of
      participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu
      Pills, one third of participanta will receive Ferrous Sulfate，and the another third will
      receive Buxue Yimu Pills and Ferrous Sulfate in combination.
Buxue Yimu Pills, Ferrous Sulfate each Improve anemia, but they do so by different
      machanisms. We generally treat patients with uncomplicated Iron Deficiency Anemia with oral
      iron due to the ease of administration，and Ferrous Sulfate is one of the most commonly used
      drugs.

      Buxue Yimu Pills consists of multiple chinses herbs including Angelica
      Sinensis，Astragalus，Donkey-Hide Gelatin，Herba Leonuri，Citrus etc., which gains widespread
      application in the treatment after women's abortion or operations of uterine cavity. Based on
      the characteristics above, we try to explore its clinical application value in Gynecological
      Iron-Deficiency Anemia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Complete Blood Count
time frame: 5 minutes
description: Anemia Related Assessment
measure: The Short Form-36 Health Survey (Sf-36)
time frame: 10 minutes
description: Information about health
measure: Hepatic Function
time frame: 5 minutes
description: Safety Monitoring
measure: Renal Function
time frame: 5 minutes
description: Safety Monitoring
measure: Blood Glucose
time frame: 5 minutes
description: Safety Monitoring
measure: Electrolyte Semiconductor Junction
time frame: 5 minutes
description: Safety Monitoring
measure: Electrocardiogram(ECG)
time frame: 5 minutes
description: Safety Monitoring
measure: Iron Metabolism index
time frame: 5 minutes
description: Anemia Related Assessment
measure: Metabonomics Measurement
time frame: 1hour
description: Extensive and profound Information
arm group label: Buxue Yimu Pills
arm group type: Experimental
description: Buxue Yimu Pill 12g pill by mouth, twice daily
arm group label: Buxue Yimu Pills &Ferrous Sulfate
arm group type: Experimental
description: Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
arm group label: Ferrous Sulfate
arm group type: Active Comparator
description: Ferrous Sulfate 0.3g tablet by mouth, three times daily
intervention type: Drug
intervention name: Buxue Yimu Pills
description: Buxue Yimu Pills 12g pill by mouth, twice daily.
arm group label: Buxue Yimu Pills
other name: Buxue Yimu pellets
intervention type: Drug
intervention name: Buxue Yimu Pills &Ferrous Sulfate
description: Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
arm group label: Buxue Yimu Pills &Ferrous Sulfate
other name: Buxue Yimu pellets,Iron Sulfate
intervention type: Drug
intervention name: Ferrous Sulfate
description: Ferrous Sulfate 0.3g tablet by mouth, three times daily
arm group label: Ferrous Sulfate
other name: Iron Sulfate
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Aijun AJ Sun, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
last name: Lei L Li, MD
phone: 139-1198-8831
phone ext: ＋86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406716/
description: Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.
citation: Percy L, Mansour D, Fraser I. Iron deficiency and iron deficiency anaemia in women. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:55-67. doi: 10.1016/j.bpobgyn.2016.09.007. Epub 2016 Oct 1.
PMID: 28029503
citation: Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.
PMID: 28487769
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Aijun Sun
investigator title: Professor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Iron
sharing ipd: Yes
ipd description: Network platform, and the website will be attached later.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within 2 months after the trial complete
ipd access criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
provided document: 
provided document: 