xml: <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/NCT05976308</url>
    </required_header>
    <id_info>
      <org_study_id>20223BBG71012-1</org_study_id>
      <nct_id>NCT05976308</nct_id>
    </id_info>
    <brief_title>Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome</brief_title>
    <official_title>Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome : a Double-blind, Randomized and Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangxi University of Traditional Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangxi University of Traditional Chinese Medicine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine&#xD;
        and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial&#xD;
        for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear,&#xD;
        because the quantity of pre-clinical data was limited and the quality of clinical evidence&#xD;
        was variable. Therefore, this randomized double-blind placebo-controlled trial aim to&#xD;
        evaluate the efficacy of Chinese herbal medicine (Bushen Huatan Decoction) in women with&#xD;
        PCOS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>Phase 1/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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ovulation rate</measure>
      <time_frame>3 months</time_frame>
      <description>Ovulation rate in each group during the study period</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>Therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bushen Huatan Decoction</intervention_name>
      <description>The treatment group used Bushen Huatan Decoction, including Tusizi (the seed of Chinese dodder), Fupenzi (Raspberry), Bajitian (Morinda officinalis), Duzhong (Eucommia ulmoides), Shudi (prepared Rehmanniaroot), Fuling (Tuckahoe), Zelan (Aconitum gymnandrum), Zexie (Rhizoma alismatis), Guizhi (Cassia twig), Zhebeimu (Thunberg Fritillary Bulb), Taoren (Peach kernel) and Chuanxiong (Ligusticum wallichii). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.</description>
      <arm_group_label>Therapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The diagnosis of PCOS is based on the Rotterdam criteria.&#xD;
  &#xD;
            2. Meet the syndrome differentiation standard of kidney-yang deficiency with&#xD;
               phlegm-dampness and blood stasis in TCM theory.&#xD;
  &#xD;
            3. women aged 18-40 years without fertility requirements.&#xD;
  &#xD;
            4. A willingness to undergo this treatment plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one&#xD;
               week apart).&#xD;
  &#xD;
            2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10&#xD;
               IU/L.&#xD;
  &#xD;
            3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2&#xD;
               mIU/mL or more than 5.5 mIU/mL.&#xD;
  &#xD;
            4. Suspected Cushing's syndrome.&#xD;
  &#xD;
            5. Adrenal or ovarian tumors secreting androgen.&#xD;
  &#xD;
            6. Poorly controlled type II diabetes.&#xD;
  &#xD;
            7. Pregnancy or lactation.&#xD;
  &#xD;
            8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure&#xD;
               more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).&#xD;
  &#xD;
            9. Those who had taken hormones or other drugs during the previous 3 months.&#xD;
  &#xD;
           10. Acute heart, liver, kidney or blood diseases.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ruining Liang</last_name>
      <phone>0086-0791-88385243</phone>
      <email>jack169@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ruining Liang</last_name>
        <phone>0086-0791-88385243</phone>
        <email>jack169@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jiangxi University of Traditional Chinese Medicine</investigator_affiliation>
      <investigator_full_name>Ruining Liang</investigator_full_name>
      <investigator_title>chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976308
  org study id: 20223BBG71012-1
  nct id: NCT05976308
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine
        and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial
        for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear,
        because the quantity of pre-clinical data was limited and the quality of clinical evidence
        was variable. Therefore, this randomized double-blind placebo-controlled trial aim to
        evaluate the efficacy of Chinese herbal medicine (Bushen Huatan Decoction) in women with
        PCOS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Ovulation rate
  time frame: 3 months
  description: Ovulation rate in each group during the study period
  arm group label: Therapy group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Bushen Huatan Decoction
  description: The treatment group used Bushen Huatan Decoction, including Tusizi (the seed of Chinese dodder), Fupenzi (Raspberry), Bajitian (Morinda officinalis), Duzhong (Eucommia ulmoides), Shudi (prepared Rehmanniaroot), Fuling (Tuckahoe), Zelan (Aconitum gymnandrum), Zexie (Rhizoma alismatis), Guizhi (Cassia twig), Zhebeimu (Thunberg Fritillary Bulb), Taoren (Peach kernel) and Chuanxiong (Ligusticum wallichii). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.
  arm group label: Therapy group
  intervention type: Drug
  intervention name: Placebo
  description: The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.
  arm group label: Control group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Ruining Liang
  phone: 0086-0791-88385243
  email: jack169@sina.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Jiangxi University of Traditional Chinese Medicine
  investigator full name: Ruining Liang
  investigator title: chief physician
  mesh term: Polycystic Ovary Syndrome
  mesh term: Syndrome