<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/NCT02972151</url>
  </required_header>
  <id_info>
    <org_study_id>42501190</org_study_id>
    <nct_id>NCT02972151</nct_id>
  </id_info>
  <brief_title>Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae</brief_title>
  <official_title>Clinical Promotion Research of Complex Treatment With TCM to Diagnosis and Treatment on Different Syndrome Types of Pelvic Inflammatory Disease Sequelae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial attempts to optimize, standardize and simplify the characteristic diagnosis and&#xD;
      treatment program of the dominant diseases in our hospital-the sequelae of pelvic&#xD;
      inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in&#xD;
      primary hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sequelae of pelvic inflammatory disease (SPID) is a common cause of chronic pelvic pain,&#xD;
      ectopic pregnancy and infertility, which seriously affects the physical and mental health of&#xD;
      the patients, quality of life and family happiness. Western medicine for pelvic inflammatory&#xD;
      disease sequelae is still lack of effective treatment methods, traditional Chinese medicine&#xD;
      treatment of this disease has a unique advantage, with broad prospects for&#xD;
      development..Standardized diagnosis and treatment scheme of this project on the one hand,&#xD;
      improve and optimize the sequelae of pelvic inflammatory disease, including according to the&#xD;
      dialectical treatment of herbal medicine combined with TCM (traditional Chinese medicine&#xD;
      enema, external application of Chinese medicine intervention treatment); on the other hand,&#xD;
      to observe the clinical curative effect and adverse reaction of traditional Chinese medicine&#xD;
      comprehensive treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes of The Symptom score</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Patients are checked The Symptom score at 3 months after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes of The Hamilton Depression Scale (HAMD) (17 items)</measure>
    <time_frame>1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of The Sign score sheet</measure>
    <time_frame>1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">175</enrollment>
  <condition>Pelvic Inflammatory Disease</condition>
  <arm_group>
    <arm_group_label>Comprehensive treatment of TCM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expectant therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Expectant treatment group patients were not treated during the observation period.&#xD;
（3 months after the start of the trial and 1 months after the end of the trial.）</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Comprehensive treatment of TCM</intervention_name>
    <description>Subjects were treated with comprehensive treatment of TCM including Oral medicine: 1 dose daily by our hospital pharmacy medicine room Decoction decoction, each agent 200ml, and the 2 ton service. 10 days for a course of treatment, continuous treatment of 3 courses; retention enema with traditional Chinese medicine oral drugs according to different types of concentrated decoction enema, each dose of medicine decocting 2 times, 2 days of external application of Chinese medicine: Chinese medicine enema; break into powder, into the bag, steam for 45 minutes, and so the temperature dropped to appropriate, will be installed a Chinese medicine bag used on patients with lower abdomen for 20 minutes. Above method, a course of treatment for 10 days, continuous treatment of 3 courses.</description>
    <arm_group_label>Comprehensive treatment of TCM</arm_group_label>
    <other_name>Oral medicine and TCM enema, external treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Expectant treatment</intervention_name>
    <description>Expectant treatment group patients were not treated during the observation period.（3 months after the start of the trial and 1 months after the end of the trial.）From the point of view of medical ethics, the expectant treatment group of patients at the end of the observation period, given the treatment of traditional Chinese medicine treatment group.</description>
    <arm_group_label>Expectant therapy</arm_group_label>
    <other_name>Do not give any treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with diagnostic criteria for the sequelae of pelvic inflammatory disease in&#xD;
             Western medicine;&#xD;
&#xD;
          2. Patients conforming to the criteria of TCM syndrome differentiation;&#xD;
&#xD;
          3. Age 18--60 years old, married or sexual life;&#xD;
&#xD;
          4. In this study, the voluntary participation, and signed informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not meet the diagnostic criteria of Western medicine and traditional&#xD;
             Chinese medicine dialectical typing standard;&#xD;
&#xD;
          2. Persons with acute pelvic inflammatory disease;&#xD;
&#xD;
          3. Related symptoms caused by diseasesGynecological tumor，specific vaginitis, acute&#xD;
             cervicitis, pelvic congestion syndrome, endometriosis, adenomyosis, pelvic&#xD;
             tuberculosis etc.&#xD;
&#xD;
          4. Pregnant and lactating women;&#xD;
&#xD;
          5. With severe primary disease, such as liver, kidney, heart, brain and hematopoietic&#xD;
             system;&#xD;
&#xD;
          6. Allergic to a variety of drugs or known to be allergic to the composition of the use&#xD;
             of traditional Chinese Medicine;&#xD;
&#xD;
          7. Patients taking part in other clinical trials;&#xD;
&#xD;
          8. Suspect or do have a history of alcohol, drug abuse or according to the judgment of&#xD;
             the researcher,other lesions or circumstances that have reduced the likelihood of&#xD;
             entering a group or the complexity of entering a group,such as frequent changes in the&#xD;
             working environment, the living environment is not stable,etc.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>lianwei xu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Longhua Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>lianwei xu, Doctor</last_name>
    <phone>64385700-3912</phone>
    <email>sherryxlw@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>qianjue tang</last_name>
    <phone>64385700-3912</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Longhua Hosptial</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>lianwei xu, Doctor</last_name>
      <phone>64385700-3912</phone>
      <email>sherryxlw@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>lianwei xu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02972151
org study id: 42501190
nct id: NCT02972151
lead sponsor: 
has dmc: Yes
The trial attempts to optimize, standardize and simplify the characteristic diagnosis and
      treatment program of the dominant diseases in our hospital-the sequelae of pelvic
      inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in
      primary hospital.
Sequelae of pelvic inflammatory disease (SPID) is a common cause of chronic pelvic pain,
      ectopic pregnancy and infertility, which seriously affects the physical and mental health of
      the patients, quality of life and family happiness. Western medicine for pelvic inflammatory
      disease sequelae is still lack of effective treatment methods, traditional Chinese medicine
      treatment of this disease has a unique advantage, with broad prospects for
      development..Standardized diagnosis and treatment scheme of this project on the one hand,
      improve and optimize the sequelae of pelvic inflammatory disease, including according to the
      dialectical treatment of herbal medicine combined with TCM (traditional Chinese medicine
      enema, external application of Chinese medicine intervention treatment); on the other hand,
      to observe the clinical curative effect and adverse reaction of traditional Chinese medicine
      comprehensive treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes of The Symptom score
time frame: 3 months after treatment
description: Patients are checked The Symptom score at 3 months after treatment.
measure: changes of The Hamilton Depression Scale (HAMD) (17 items)
time frame: 1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal.
measure: changes of The Sign score sheet
time frame: 1 months after treatment, 2 months after treatment, 3 months after treatment and 1 months after drug withdrawal
arm group label: Comprehensive treatment of TCM
arm group type: Experimental
description: The intervention is Comprehensive treatment of TCM,which including Oral medicine ,tradition chinese medicine enema, external treatment.
arm group label: Expectant therapy
arm group type: Active Comparator
description: Expectant treatment group patients were not treated during the observation period.
（3 months after the start of the trial and 1 months after the end of the trial.）
intervention type: Drug
intervention name: Comprehensive treatment of TCM
description: Subjects were treated with comprehensive treatment of TCM including Oral medicine: 1 dose daily by our hospital pharmacy medicine room Decoction decoction, each agent 200ml, and the 2 ton service. 10 days for a course of treatment, continuous treatment of 3 courses; retention enema with traditional Chinese medicine oral drugs according to different types of concentrated decoction enema, each dose of medicine decocting 2 times, 2 days of external application of Chinese medicine: Chinese medicine enema; break into powder, into the bag, steam for 45 minutes, and so the temperature dropped to appropriate, will be installed a Chinese medicine bag used on patients with lower abdomen for 20 minutes. Above method, a course of treatment for 10 days, continuous treatment of 3 courses.
arm group label: Comprehensive treatment of TCM
other name: Oral medicine and TCM enema, external treatment
intervention type: Other
intervention name: Expectant treatment
description: Expectant treatment group patients were not treated during the observation period.（3 months after the start of the trial and 1 months after the end of the trial.）From the point of view of medical ethics, the expectant treatment group of patients at the end of the observation period, given the treatment of traditional Chinese medicine treatment group.
arm group label: Expectant therapy
other name: Do not give any treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: lianwei xu, Doctor
role: Principal Investigator
affiliation: Shanghai Longhua Hospital
last name: lianwei xu, Doctor
phone: 64385700-3912
email: sherryxlw@hotmail.com
last name: qianjue tang
phone: 64385700-3912
facility: 
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Pelvic Inflammatory Disease
mesh term: Pelvic Infection
sharing ipd: No