FuKe Qianjin Capsule Plus Antibiotics for Chronic Endometritis

Plain-language summary

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. Approximately 300 eligible participants (confirmed CE via hysteroscopy/pathology, matching TCM syndrome, regular menstrual cycles, informed consent) will be enrolled across 10-15 Chinese centers, with exclusion for acute infections, gynecological malignancies/ severe uterine lesions, organ dysfunction, uncontrolled systemic diseases, pregnancy/lactation, 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/capsule, 2 capsules three times daily) or Control Group (56 days of matched capsule placebo). The study includes a 28-day screening period, 56-day treatment phase, and 6-month post-treatment follow-up (in-person visits at Day 28±5/56±7; telephone/outpatient follow-up at 3/6 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. The team monitors known drug adverse effects (mild gastrointestinal/skin/neurological symptoms for the capsules; gastrointestinal/photosensitivity/rare liver/blood 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/specimens are confidential, de-identified, and used only for study research (no commercial use). Overseen 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.

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