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/NCT05976295</url>
    </required_header>
    <id_info>
      <org_study_id>20223BBG71012-2</org_study_id>
      <nct_id>NCT05976295</nct_id>
    </id_info>
    <brief_title>Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome</brief_title>
    <official_title>Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial</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 (Jianpi Qushi Huatan Decoction) in women&#xD;
        with PCOS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 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>Jianpi Qushi Huatan Decoction</intervention_name>
      <description>The treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will take the medication from the first day of inclusion, dissolving and consuming one packet twice a day (morning and evening) for a total of three months.</description>
      <arm_group_label>Therapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The control group will receive a placebo treatment.</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 spleen deficiency and phlegm-dampness in&#xD;
               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>Liang Ruining</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>Nancang</city>
          <state>Jiangxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liang Ruining</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/NCT05976295
  org study id: 20223BBG71012-2
  nct id: NCT05976295
  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 (Jianpi Qushi 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: Jianpi Qushi Huatan Decoction
  description: The treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will take the medication from the first day of inclusion, dissolving and consuming one packet twice a day (morning and evening) for a total of three months.
  arm group label: Therapy group
  intervention type: Drug
  intervention name: Placebo
  description: The control group will receive a placebo treatment.
  arm group label: Control group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Liang Ruining
  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