<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/NCT03251560</url>
  </required_header>
  <id_info>
    <org_study_id>PID201706</org_study_id>
    <nct_id>NCT03251560</nct_id>
  </id_info>
  <brief_title>The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation</brief_title>
  <official_title>The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aijun Sun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen maternal and child health care hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      A prospective random control clinical trials to research Fuke Qianjin capsule's effects on&#xD;
      ameliorating the pain caused by chronic pelvic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fuke Qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused&#xD;
      by chronic pelvic disease.But random control trials on its effects are few.Our study was&#xD;
      designed as a prospective random control clinical trials to research its effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale Score(VAS score) of pelvic pain</measure>
    <time_frame>5 minutes</time_frame>
    <description>pelvic pain degree related assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reaction protein(CRP)</measure>
    <time_frame>5 minutes</time_frame>
    <description>inflammation response biomarker assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 6 (IL-6)</measure>
    <time_frame>5 minutes</time_frame>
    <description>pro-inflammatory cytokine assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor necrosis factor alpha (TNFα)</measure>
    <time_frame>5 minutes</time_frame>
    <description>systemic inflammation biomarker assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Short Form (36) Health Survey (SF-36)</measure>
    <time_frame>5 minutes</time_frame>
    <description>health status measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-form McGill Pain Questionnaire (SF-MPQ)</measure>
    <time_frame>5 minutes</time_frame>
    <description>pain assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Chronic Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Fuke Qianjin capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo pills, 2 pills each time,three times a day, orally, for 2months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fuke Qianjin capsule</intervention_name>
    <description>Fuke Qianjin capsule 0.8g pills by mouth, three times daily</description>
    <arm_group_label>Fuke Qianjin capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo oral capsule 0.8g pill by mouth, three times daily</description>
    <arm_group_label>Placebo oral capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is a female between the age of 18 and 50.&#xD;
&#xD;
          -  Subject with a history of pelvic inflammatory disease suffered from one of the&#xD;
             symptoms below and one of the signs below: symptoms:1.lower abdominal distension or&#xD;
             pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with&#xD;
             mild tenderness palpated on one side or both sides of the uterine;2.restricted&#xD;
             movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden&#xD;
             with mild tenderness.&#xD;
&#xD;
          -  Subject VAS score of pelvic pain ≥4&#xD;
&#xD;
          -  Subject without fertility requirements in 2 months&#xD;
&#xD;
          -  Subject provides written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject underwent recurrent urinary system infection or interstitial cystitis&#xD;
&#xD;
          -  Subject underwent irritable bowel syndrome&#xD;
&#xD;
          -  Subject has other complications in addition to chronic pelvis inflammation diseases&#xD;
             leading to chronic pelvic pain,such as gynecological malignant disease,irregular&#xD;
             vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter &gt;5cm by&#xD;
             ultrasound&#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 chronic pelvic pain treatment including&#xD;
             antibiotics,paregoric,physiotherapy or any other related treatment within 1month prior&#xD;
             to randomization.&#xD;
&#xD;
          -  Subject has mental disorder incapable of elementary cooperations.&#xD;
&#xD;
          -  Subject has an allergic history to the experimental drug.&#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 Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, MD</last_name>
    <phone>13911988831</phone>
    <phone_ext>+86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>China/Beiing</state>
        <zip>100000</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.uptodate.com/contents/causes-of-chronic-pelvic-pain-in-women?source=Out%20of%20date%20-%20zh-Hans&amp;search=%E6%85%A2%E6%80%A7%E7%9B%86%E8%85%94%E7%82%8E&amp;selectedTitle=4~150</url>
    <description>Causes of chronic pelvic pain in women</description>
  </link>
  <reference>
    <citation>Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.</citation>
    <PMID>25162265</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Fuke Qianjin capsule</keyword>
  <keyword>chronic pelvic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Inflammatory Disease</mesh_term>
    <mesh_term>Pelvic Infection</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_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>
  <!-- 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/NCT03251560
org study id: PID201706
nct id: NCT03251560
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A prospective random control clinical trials to research Fuke Qianjin capsule's effects on
      ameliorating the pain caused by chronic pelvic disease.
Fuke Qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused
      by chronic pelvic disease.But random control trials on its effects are few.Our study was
      designed as a prospective random control clinical trials to research its effects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analogue Scale Score(VAS score) of pelvic pain
time frame: 5 minutes
description: pelvic pain degree related assessment
measure: C-reaction protein(CRP)
time frame: 5 minutes
description: inflammation response biomarker assessment
measure: Interleukin 6 (IL-6)
time frame: 5 minutes
description: pro-inflammatory cytokine assessment
measure: Tumor necrosis factor alpha (TNFα)
time frame: 5 minutes
description: systemic inflammation biomarker assessment
measure: The Short Form (36) Health Survey (SF-36)
time frame: 5 minutes
description: health status measure
measure: Short-form McGill Pain Questionnaire (SF-MPQ)
time frame: 5 minutes
description: pain assessment
arm group label: Fuke Qianjin capsule
arm group type: Experimental
description: Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,
arm group label: Placebo oral capsule
arm group type: Placebo Comparator
description: placebo pills, 2 pills each time,three times a day, orally, for 2months
intervention type: Drug
intervention name: Fuke Qianjin capsule
description: Fuke Qianjin capsule 0.8g pills by mouth, three times daily
arm group label: Fuke Qianjin capsule
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo oral capsule 0.8g pill by mouth, three times daily
arm group label: Placebo oral capsule
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Aijun Sun, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences
last name: Lei Li, MD
phone: 13911988831
phone ext: +86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
url: https://www.uptodate.com/contents/causes-of-chronic-pelvic-pain-in-women?source=Out%20of%20date%20-%20zh-Hans&search=%E6%85%A2%E6%80%A7%E7%9B%86%E8%85%94%E7%82%8E&selectedTitle=4~150
description: Causes of chronic pelvic pain in women
citation: Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.
PMID: 25162265
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Aijun Sun
investigator title: professor
mesh term: Pelvic Inflammatory Disease
mesh term: Pelvic Infection
mesh term: Inflammation
mesh term: Pelvic Pain
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.