Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03251560
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2017-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'half of the participants will receive Fuke Qianjin capsule, the other half participants will receive placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-02', 'studyFirstSubmitDate': '2017-08-13', 'studyFirstSubmitQcDate': '2017-08-13', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale Score(VAS score) of pelvic pain', 'timeFrame': '5 minutes', 'description': 'pelvic pain degree related assessment'}, {'measure': 'C-reaction protein(CRP)', 'timeFrame': '5 minutes', 'description': 'inflammation response biomarker assessment'}, {'measure': 'Interleukin 6 (IL-6)', 'timeFrame': '5 minutes', 'description': 'pro-inflammatory cytokine assessment'}, {'measure': 'Tumor necrosis factor alpha (TNFα)', 'timeFrame': '5 minutes', 'description': 'systemic inflammation biomarker assessment'}], 'secondaryOutcomes': [{'measure': 'The Short Form (36) Health Survey (SF-36)', 'timeFrame': '5 minutes', 'description': 'health status measure'}, {'measure': 'Short-form McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': '5 minutes', 'description': 'pain assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fuke Qianjin capsule', 'chronic pelvic pain'], 'conditions': ['Chronic Pelvic Pain']}, 'referencesModule': {'references': [{'pmid': '25162265', 'type': 'BACKGROUND', 'citation': 'Steege JF, Siedhoff MT. Chronic pelvic pain. Obstet Gynecol. 2014 Sep;124(3):616-629. doi: 10.1097/AOG.0000000000000417.'}], 'seeAlsoLinks': [{'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', 'label': 'Causes of chronic pelvic pain in women'}, {'url': 'https://www.clinicalkey.com/#!/content/book/3-s2.0-B9781455770083000053?scrollTo=%23hl0001217', 'label': 'Chronic Pelvic Inflammatory Disease'}]}, 'descriptionModule': {'briefSummary': "A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a female between the age of 18 and 50.\n* Subject with a history of pelvic inflammatory disease suffered from one of the symptoms below and one of the signs below: symptoms:1.lower abdominal distension or pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with mild tenderness palpated on one side or both sides of the uterine;2.restricted movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden with mild tenderness.\n* Subject VAS score of pelvic pain ≥4\n* Subject without fertility requirements in 2 months\n* Subject provides written informed consent.\n\nExclusion Criteria:\n\n* Subject underwent recurrent urinary system infection or interstitial cystitis\n* Subject underwent irritable bowel syndrome\n* Subject has other complications in addition to chronic pelvis inflammation diseases leading to chronic pelvic pain,such as gynecological malignant disease,irregular vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter \\>5cm by ultrasound\n* Subject is pregnant or lactating.\n* Subject has a severe systemic disease, such as cardiovascular system\n* Subject has a history of malignancy or radiotherapy.\n* Subject has undergone any chronic pelvic pain treatment including antibiotics,paregoric,physiotherapy or any other related treatment within 1month prior to randomization.\n* Subject has mental disorder incapable of elementary cooperations.\n* Subject has an allergic history to the experimental drug.\n* Subject has participated in other clinical researches of medicine within 1month prior to randomization.'}, 'identificationModule': {'nctId': 'NCT03251560', 'briefTitle': 'The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation', 'orgStudyIdInfo': {'id': 'PID201706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fuke Qianjin capsule', 'description': 'Fuke Qianjin capsule, 2 pills each time,three times a day, orally (0.4g/pill）,for 2months,', 'interventionNames': ['Drug: Fuke Qianjin capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral capsule', 'description': 'placebo pills, 2 pills each time,three times a day, orally, for 2months', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Fuke Qianjin capsule', 'type': 'DRUG', 'description': 'Fuke Qianjin capsule 0.8g pills by mouth, three times daily', 'armGroupLabels': ['Fuke Qianjin capsule']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo oral capsule 0.8g pill by mouth, three times daily', 'armGroupLabels': ['Placebo oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'China/Beiing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei L Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831', 'phoneExt': '+86'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Aijun Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 2 months after the trial complete', 'ipdSharing': 'YES', 'description': 'Network platform, and the website will be attached later.', 'accessCriteria': 'Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aijun Sun', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Shenzhen maternal and child health care hospital', 'class': 'UNKNOWN'}, {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Aijun Sun', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}