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/NCT05970783</url>
    </required_header>
    <id_info>
      <org_study_id>Z-JCP-T-Ⅲ-2021-BJKC-01</org_study_id>
      <nct_id>NCT05970783</nct_id>
    </id_info>
    <brief_title>A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Dose-parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Jincaopian Tablets in Subjects With Chronic Pelvic Pain After Pelvic Inflammatory Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Konruns Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Konruns Pharmaceutical Co., Ltd.</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>
        The objective of this phase III trial to evaluate the efficacy and safety of Jincaopian&#xD;
        Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory&#xD;
        disease&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic pelvic pain is the major sequela of pelvic inflammatory disease and it's a common,&#xD;
        burdensome, and costly condition that disproportionately affects women. This multicenter,&#xD;
        randomized, double-blind, dose-parallel, placebo-controlled phase III clinical trial is&#xD;
        designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of&#xD;
        subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 414&#xD;
        subjects were enrolled and randomized to either &quot;Jincaopian Tablets&quot; group, or the &quot;placebo&quot;&#xD;
        group in a 2:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 8, 2022</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>Phase 3</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>Pain disappearance rate after 12 weeks of treatment</measure>
      <time_frame>12 Weeks</time_frame>
      <description>The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain disappearance rate after 4 and 8 weeks of treatment</measure>
      <time_frame>8 Weeks</time_frame>
      <description>The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment</measure>
      <time_frame>12 Weeks</time_frame>
      <description>Visual Analogue Scale (VAS) was used to evaluate pelvic pain degree. The VAS score ranged from 0 to 10, and a higher score represented greater pain intensity. The average VAS value for a week was calculated by dividing the sum of the scores for each day of the week by the number of days the score was recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The area under the VAS score-time curve</measure>
      <time_frame>12 Weeks</time_frame>
      <description>AUC under the curve to evaluating pain levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>McCormick Scale</measure>
      <time_frame>12 Weeks</time_frame>
      <description>The McCormack scale was used to score the patient's physical signs. The total score is 36 points, rated from twelve aspects including uterine tenderness (divided into four quadrants), abdominal tenderness or rebound pain (divided into four quadrants), left or right adnexal tenderness, uterine tenderness, and cervical lifting and swinging pain. The scoring criteria was as following: no pain is 0 points; Mild pain without facial expression changes and muscle tension is 1 point; Pain accompanied by facial expressions and muscle tension is 2 points; Pain drama is 3 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General quality of life (Short Form-12) scale</measure>
      <time_frame>12 Weeks</time_frame>
      <description>The Short Form-12 is an abbreviated version of the original 36-item QOL questionnaire. It comprises 12 items with a mental component summary (MCS) and a physical component summary (PCS). Possible scores for mental and physical health-related QOL subscales range from 0 to 100 points, and a higher score is interpreted as better QOL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease efficacy evaluation</measure>
      <time_frame>12 Weeks</time_frame>
      <description>Disease efficacy was determined based on the change of the clinical signs and symptoms.&#xD;
  Based on the evaluation criteria, the Disease efficacy was recorded as Clinical recovery, significant effect, effectiveness, and ineffectiveness.&#xD;
  Clinical recovery: The symptoms and signs disappear, and the integral values of symptoms, signs, and auxiliary examinations decrease by ≥ 95%.&#xD;
  Significant effect: The symptoms and signs are significantly reduced, with a reduction of ≥ 70% and&lt;95% in the score of symptoms, signs, and auxiliary examinations.&#xD;
  Effective: Symptoms and signs have been alleviated, with a reduction of ≥ 30% and&lt;70% in symptom, sign, and auxiliary examination scores.&#xD;
  Invalid: No reduction or aggravation of symptoms and signs, with a decrease of&lt;30% in the score of symptoms, signs, and auxiliary examinations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events (AEs)</measure>
      <time_frame>12 Weeks</time_frame>
      <description>Incidence of treatment-related AEs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">414</enrollment>
    <condition>Chronic Pelvic Pain</condition>
    <arm_group>
      <arm_group_label>Jincaopian Tablets group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive Jincaopian Tablets 0.6g/day for 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients receive a placebo 0.6g/day for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Jincaopian Tablets</intervention_name>
      <description>Jincaopian Tablets 0.2g tid p.o.</description>
      <arm_group_label>Jincaopian Tablets group</arm_group_label>
      <other_name>ZY5301</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo 0.2g tid p.o.</description>
      <arm_group_label>Placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meet the diagnostic criteria for chronic pelvic pain sequelae of pelvic inflammatory&#xD;
               disease;&#xD;
  &#xD;
            -  The average VAS score of pain in the week before enrollment is ≥4;&#xD;
  &#xD;
            -  The McCormack scale of physical signs at the time of enrollment is 4 to 12 points&#xD;
               (including 4 points and 12 points);&#xD;
  &#xD;
            -  Women aged 18 to 50 (including 18 and 50) with a history of sexual life;&#xD;
  &#xD;
            -  Voluntarily participate in this clinical trial, give informed consent and sign the&#xD;
               informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pelvic inflammatory disease (acute attack);&#xD;
  &#xD;
            -  Pregnant or lactating women, women of childbearing age who are unwilling to take&#xD;
               effective measures to prevent pregnancy during the trial and within 6 months after the&#xD;
               trial;&#xD;
  &#xD;
            -  Previously diagnosed with cervical intraepithelial neoplasia, primary/secondary&#xD;
               dysmenorrhea, pelvic stasis syndrome and chronic pelvic pain caused by other&#xD;
               non-pelvic inflammatory diseases;&#xD;
  &#xD;
            -  Complicated with specific vaginitis such as vulvovaginal candidiasis, trichomonas&#xD;
               vaginitis, bacterial vaginosis;&#xD;
  &#xD;
            -  Gynecological tumors (maximum diameter of uterine fibroids greater than 3cm and&#xD;
               submucosal fibroids), endometriosis, adenomyosis, acute cervicitis, tuberculous pelvic&#xD;
               inflammatory disease, interstitial cystitis and other diseases related symptoms;&#xD;
  &#xD;
            -  Placement of intrauterine device in the past 3 months; absence of uterus and bilateral&#xD;
               appendages;&#xD;
  &#xD;
            -  Received related treatment or took drugs with similar functions and indications within&#xD;
               14 days before the introduction;&#xD;
  &#xD;
            -  Liver function: ALT or AST&gt;1.5 times the upper limit of normal value；Renal&#xD;
               function：Scr&gt;1.0 times the upper limit of normal value;&#xD;
  &#xD;
            -  Serum CA125 and erythrocyte sedimentation &gt; 1.1 times the upper limit of normal value.&#xD;
  &#xD;
            -  Combined with serious cardiovascular, cerebrovascular, hematopoietic system and other&#xD;
               serious diseases;&#xD;
  &#xD;
            -  Have an allergic history to the experimental drug;&#xD;
  &#xD;
            -  Have a long history of alcoholism or drug abuse;&#xD;
  &#xD;
            -  Intellectual disabilities or mental disorders;&#xD;
  &#xD;
            -  Participated in other clinical trials within the past 3 months;&#xD;
  &#xD;
            -  The investigator believes that it is not suitable to participate in this clinical&#xD;
               trial.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiuxiang Teng</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiuxiang Teng</last_name>
      <phone>+86 010-87906734</phone>
      <email>tengxx@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiuxiang Teng</last_name>
        <phone>+86 010-87906734</phone>
        <email>tengxx@126.com</email>
      </contact>
      <investigator>
        <last_name>Xiuxiang Teng</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Pelvic Inflammatory Disease</mesh_term>
      <mesh_term>Pelvic Infection</mesh_term>
      <mesh_term>Pelvic Pain</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/NCT05970783
  org study id: Z-JCP-T-Ⅲ-2021-BJKC-01
  nct id: NCT05970783
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this phase III trial to evaluate the efficacy and safety of Jincaopian
        Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory
        disease
  Chronic pelvic pain is the major sequela of pelvic inflammatory disease and it's a common,
        burdensome, and costly condition that disproportionately affects women. This multicenter,
        randomized, double-blind, dose-parallel, placebo-controlled phase III clinical trial is
        designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of
        subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 414
        subjects were enrolled and randomized to either "Jincaopian Tablets" group, or the "placebo"
        group in a 2:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Pain disappearance rate after 12 weeks of treatment
  time frame: 12 Weeks
  description: The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
  measure: Pain disappearance rate after 4 and 8 weeks of treatment
  time frame: 8 Weeks
  description: The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
  measure: Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment
  time frame: 12 Weeks
  description: Visual Analogue Scale (VAS) was used to evaluate pelvic pain degree. The VAS score ranged from 0 to 10, and a higher score represented greater pain intensity. The average VAS value for a week was calculated by dividing the sum of the scores for each day of the week by the number of days the score was recorded.
  measure: The area under the VAS score-time curve
  time frame: 12 Weeks
  description: AUC under the curve to evaluating pain levels
  measure: McCormick Scale
  time frame: 12 Weeks
  description: The McCormack scale was used to score the patient's physical signs. The total score is 36 points, rated from twelve aspects including uterine tenderness (divided into four quadrants), abdominal tenderness or rebound pain (divided into four quadrants), left or right adnexal tenderness, uterine tenderness, and cervical lifting and swinging pain. The scoring criteria was as following: no pain is 0 points; Mild pain without facial expression changes and muscle tension is 1 point; Pain accompanied by facial expressions and muscle tension is 2 points; Pain drama is 3 points.
  measure: General quality of life (Short Form-12) scale
  time frame: 12 Weeks
  description: The Short Form-12 is an abbreviated version of the original 36-item QOL questionnaire. It comprises 12 items with a mental component summary (MCS) and a physical component summary (PCS). Possible scores for mental and physical health-related QOL subscales range from 0 to 100 points, and a higher score is interpreted as better QOL.
  measure: Disease efficacy evaluation
  time frame: 12 Weeks
  description: Disease efficacy was determined based on the change of the clinical signs and symptoms.
  Based on the evaluation criteria, the Disease efficacy was recorded as Clinical recovery, significant effect, effectiveness, and ineffectiveness.
  Clinical recovery: The symptoms and signs disappear, and the integral values of symptoms, signs, and auxiliary examinations decrease by ≥ 95%.
  Significant effect: The symptoms and signs are significantly reduced, with a reduction of ≥ 70% and<95% in the score of symptoms, signs, and auxiliary examinations.
  Effective: Symptoms and signs have been alleviated, with a reduction of ≥ 30% and<70% in symptom, sign, and auxiliary examination scores.
  Invalid: No reduction or aggravation of symptoms and signs, with a decrease of<30% in the score of symptoms, signs, and auxiliary examinations
  measure: Adverse events (AEs)
  time frame: 12 Weeks
  description: Incidence of treatment-related AEs
  arm group label: Jincaopian Tablets group
  arm group type: Experimental
  description: Patients receive Jincaopian Tablets 0.6g/day for 12 weeks.
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Patients receive a placebo 0.6g/day for 12 weeks.
  intervention type: Drug
  intervention name: Jincaopian Tablets
  description: Jincaopian Tablets 0.2g tid p.o.
  arm group label: Jincaopian Tablets group
  other name: ZY5301
  intervention type: Other
  intervention name: Placebo
  description: Placebo 0.2g tid p.o.
  arm group label: Placebo group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Xiuxiang Teng
  role: Principal Investigator
  affiliation: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
  last name: Xiuxiang Teng
  phone: +86 010-87906734
  email: tengxx@126.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Pelvic Inflammatory Disease
  mesh term: Pelvic Infection
  mesh term: Pelvic Pain