[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630297":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Tianjin Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Antibiotics plus FuKe Qianjin Capsules","EXPERIMENTAL","14 consecutive days of doxycycline hyclate tablets combined with 56 days of FuKe Qianjin Capsule.\n\nFuKe Qianjin Capsule: 0.4g per capsule, 2 capsules orally, three times a day; Doxycycline Hyclate Tablets: 100mg per tablet, 1 tablet (100mg) orally, twice a day.",[13],"Drug: FuKe Qianjin Capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Antibiotics plus a matching FuKe Qianjin Capsule placebo","PLACEBO_COMPARATOR","14 consecutive days of doxycycline hyclate tablets combined with 56 days of FuKe Qianjin Capsule placebo.\n\nFuKe Qianjin Capsule placebo: 0.4g per capsule,2 capsules orally, three times a day; Doxycycline Hyclate Tablets: 100mg per tablet, 1 tablet (100mg) orally, twice a day.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","FuKe Qianjin Capsules","This clinical study adopts a combined intervention regimen of first-line antibiotic therapy for chronic endometritis (CE) and Chinese herbal plant preparation, with a placebo-controlled design to evaluate the adjunctive therapeutic value of FuKe Qianjin Capsules. The identical standard antibiotic course is administered to all participants, and the herbal preparation\u002Fits matched placebo is given in a double-blind manner for an extended duration to target the chronic inflammatory characteristics of CE, with consistent administration routes, frequency and dosage forms maintained across intervention groups to ensure the uniformity of trial implementation and the reliability of efficacy and safety comparison.",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Fengxia Xue","CONTACT","+86 13902071517","lvyohu@163.com",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Wenyan Tian","tianwenyan1108@163.com",[36],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Tianjin Medical University General Hospital","Tianjin","Tianjin Municipality","300052","China","CN",{"type":44,"coordinates":45},"Point",[46,47],117.17667,39.14222,{"lat":47,"lon":46},[50,51],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":34},{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},{"type":53,"investigatorFullName":28,"investigatorTitle":54,"investigatorAffiliation":37,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Director, Department of Obstetrics and Gynecology Medical Center, Tianjin Medical University General Hospital, Tianjin China Director, Tianjin Key Laboratory of Female Reproductive Health and Eugenics, Tianjin China",[56],{"name":57,"class":58},"Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China","UNKNOWN","100630297","phase-4-fuke-qianjin-capsule-plus-antibiotics-for-chronic-endometritis-100630297",false,"NCT07485842","FuKe Qianjin Capsule Plus Antibiotics for Chronic Endometritis","Randomized, Double-Blind, Single-Simulation, Multicenter Clinical Study Evaluating the Efficacy and Safety of FuKe Qianjin Capsules in Combination With Antibiotics for the Treatment of Chronic Endometritis.","FKQJCE","Inclusion Criteria:\n\n1. Age range: 20 years old ≤ age ≤ 40 years old;\n2. Meets the diagnostic criteria for chronic endometritis;\n3. Meets the Traditional Chinese Medicine(TCM) syndrome differentiation criteria for damp-heat with deficiency of both qi and blood;\n4. Has a regular menstrual cycle, with a cycle length ≥21 days and ≤35 days;\n5. Voluntarily participates and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with concurrent acute genital tract and pelvic infections, etc.\n2. Patients with endometrial tuberculosis, endometrial cancer, or other malignant gynecological tumors.\n3. Patients with endometrial lesions, such as endometrial hyperplasia, uterine cavity adhesions, submucosal fibroids, or endometrial polyps.\n4. Patients with hydrosalpinx or pelvic abscesses.\n5. Patients with severe abnormalities in heart, liver, or kidney function.\n6. Patients with uncontrolled autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, etc.).\n7. Patients with uncontrolled endocrine or metabolic diseases (e.g., diabetes, hyperthyroidism, or hypothyroidism, etc.).\n8. Patients with mental disorders (e.g., severe depression, schizophrenia) or unable to comply with follow-up.\n9. Pregnant or breastfeeding women, or those refusing contraception during treatment.\n10. Patients with allergies to study drugs (including Chinese herbal components or antibiotics).\n11. Patients who have participated in other clinical trials within the past 3 months.\n12. Other situations where the investigator deems the patient unsuitable for participation in the study.","FEMALE","20 Years","40 Years",{"count":71,"type":72},300,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","This randomized, double-blind, single-dummy, multicenter clinical study, led by Principal Investigator Xue Fengxia at Tianjin Medical University General Hospital (sponsor and primary trial institution) and funded by Zhuzhou Qianjin Pharmaceutical Co., Ltd., evaluates the safety and efficacy of FuKe Qianjin Capsules combined with standard antibiotic therapy for chronic endometritis (CE) in women aged 20-40 years. CE, a common gynecological inflammation marked by uterine plasma cell infiltration from bacterial infection, is linked to infertility, repeated implantation failure (RIF), and recurrent miscarriage (RM); it is often underdiagnosed due to non-specific symptoms, and first-line doxycycline therapy is limited by antibiotic resistance and high recurrence. FuKe Qianjin Capsules, a nationally recognized Chinese herbal medicine for gynecological inflammations, align with traditional Chinese medicine (TCM) treatment principles for CE (damp-heat stasis with qi and blood deficiency) and reduce antibiotic resistance per domestic research.\n\nApproximately 300 eligible participants (confirmed CE via hysteroscopy\u002Fpathology, matching TCM syndrome, regular menstrual cycles, informed consent) will be enrolled across 10-15 Chinese centers, with exclusion for acute infections, gynecological malignancies\u002F severe uterine lesions, organ dysfunction, uncontrolled systemic diseases, pregnancy\u002Flactation, drug hypersensitivity, or recent trial participation. All receive 14 days of oral doxycycline (100mg twice daily) and are randomized 1:1 to two double-blind groups (150 each): Experimental Group (56 days of FuKe Qianjin Capsules, 0.4g\u002Fcapsule, 2 capsules three times daily) or Control Group (56 days of matched capsule placebo).\n\nThe study includes a 28-day screening period, 56-day treatment phase, and 6-month post-treatment follow-up (in-person visits at Day 28±5\u002F56±7; telephone\u002Foutpatient follow-up at 3\u002F6 months). Efficacy assessments (hysteroscopy, TCM scoring, ultrasound), safety monitoring (vital signs, blood work, pregnancy testing), adverse event recording, and medication adherence checks occur at all visits, with ultrasound-confirmed clinical pregnancy rate as the key post-treatment outcome.\n\nThe team monitors known drug adverse effects (mild gastrointestinal\u002Fskin\u002Fneurological symptoms for the capsules; gastrointestinal\u002Fphotosensitivity\u002Frare liver\u002Fblood issues for doxycycline) and hysteroscopy risks (mild bleeding, rare perforation), with emergency protocols in place. Participants may withdraw voluntarily at any time with no impact on regular care; all data\u002Fspecimens are confidential, de-identified, and used only for study research (no commercial use).\n\nOverseen by the hospital's Institutional Ethics Committee and compliant with national research standards, the study's primary goal is to confirm the combined regimen's superior safety and efficacy over antibiotic monotherapy for CE, as well as its ability to improve reproductive outcomes and reduce recurrence. A positive result will establish this integrated Chinese-Western medicine approach as an evidence-based CE treatment, reducing antibiotic resistance and enhancing reproductive health for affected women, especially those with infertility, RIF, or recurrent miscarriage.",[78],"Chronic Endometritis",[78,80,81,82,83],"Clinical efficacy and safety","Combination Drug Therapy","Multicenter Clinical Studies","Fuke Qianjin Capsule","NOT_YET_RECRUITING","2026-03-17",{"date":87,"type":88},"2026-03-20","ACTUAL",{"date":90,"type":72},"2026-04",{"date":92,"type":72},"2027-12",{"name":5,"class":6},1]