FuKe Qianjin Capsule Plus Antibiotics for Chronic Endometritis

This is a rigorously designed randomized, double-blind, single-dummy, multicenter interventional clinical study initiated to address the unmet clinical needs in the treatment of chronic endometritis (CE), a common chronic inflammatory gynecological disorder with a rising incidence in reproductive-age women. Led by Principal Investigator Xue Fengxia at Tianjin Medical University General Hospital, which serves as both the study sponsor and the primary clinical trial institution, the research is funded by Zhuzhou Qianjin Pharmaceutical Co., Ltd.-the exclusive manufacturer of Fuke Qianjin Capsule, the core traditional Chinese medicine (TCM) intervention in this study. The study adheres to international clinical research norms and national ethical and regulatory requirements, with full oversight by the Institutional Ethics Committee of Tianjin Medical University General Hospital, ensuring the scientificity, rigor, and ethical compliance of all research procedures and participant protections.

Chronic endometritis is defined by persistent plasma cell infiltration in the endometrial stroma, caused by bacterial invasion of the endometrium via ascending or descending pathways through the reproductive tract or lymphatic system. A striking clinical challenge of CE is its non-specific or even absent symptomatic presentation; affected patients may experience mild or atypical symptoms such as abnormal uterine bleeding, pelvic pain, dyspareunia, and abnormal vaginal discharge, which are often overlooked in routine clinical practice. Compounding this issue, conventional clinical assessments-including peripheral blood inflammatory markers (e.g., white blood cell count, serum C-reactive protein) and gynecological imaging (e.g., color Doppler ultrasound, hysterosalpingography)-lack specific diagnostic signs for CE, leading to frequent underdiagnosis and delayed treatment. Epidemiological data highlight the significant clinical burden of CE: its incidence ranges from 2.8% to 56.8% in infertile women, 14.0% to 67.5% in patients with repeated implantation failure (RIF), and 9.3% to 67.6% in those with recurrent miscarriage (RM), establishing a clear and strong link between unmanaged CE and adverse reproductive outcomes. Despite its clinical importance, there is no currently approved specific treatment regimen for CE worldwide; clinical practice relies on empirical antibiotic therapy, with doxycycline as the first-line agent and second-line combination regimens including metronidazole paired with fluoroquinolones (moxifloxacin, ofloxacin, ciprofloxacin). However, long-term and irregular antibiotic use has led to the emergence of bacterial drug resistance, resulting in suboptimal treatment efficacy in a substantial proportion of CE patients, as well as increased risks of secondary complications such as superinfection and dysbiosis of the reproductive tract flora-creating an urgent need for safe and effective adjunctive therapies to improve treatment outcomes and reduce antibiotic reliance.

Against this backdrop, the study leverages the well-documented clinical value of integrated TCM and Western medicine (TCM-WM) in managing chronic inflammatory diseases, evaluating the synergistic efficacy and safety of Fuke Qianjin Capsule combined with standard antibiotic therapy for CE. Fuke Qianjin Capsule is a nationally recognized TCM preparation, listed in both the National Essential Drugs List and the Class A National Medical Insurance List (National Medicine Approval Number Z20020024), with a long history of clinical use in treating gynecological inflammatory disorders including chronic pelvic inflammatory disease, chronic endometritis, and chronic cervicitis. Formulated with eight carefully selected medicinal herbs-Flemingia philippinensis, Rosa laevigata root, Andrographis paniculata, Mahonia fortunei, Zanthoxylum nitidum, Angelica sinensis, Spatholobus suberectus, and Codonopsis pilosula-the capsule exerts a synergistic therapeutic effect by tonifying qi and blood, clearing heat and eliminating dampness, and activating blood circulation to dissipate stasis. This formulation aligns precisely with the TCM pathological understanding of CE, which is categorized under "leukorrheal diseases", "lower abdominal pain in women", and "dysmenorrhea" and attributed to damp-heat stasis obstruction combined with qi and blood deficiency-pathogenic factors linked to postpartum uterine collateral weakness, internal invasion of pathogenic toxins, and constitutional deficiency. Domestic preclinical and clinical research has demonstrated that Fuke Qianjin Capsule can alleviate endometrial inflammation, reduce bacterial drug resistance, lower the recurrence rate of gynecological inflammatory disorders, and improve reproductive tract microenvironment-making it a promising adjunct to antibiotic therapy for CE. Notably, the capsule has a well-characterized post-marketing safety profile, with mild and transient adverse reactions reported, further supporting its suitability for long-term use in chronic disease management.

To minimize bias and ensure the reliability of study results, the research adopts a double-blind, single-dummy study design-a gold-standard methodological approach for evaluating herbal interventions alongside standard Western medicine regimens. The double-blind design ensures that both study participants and investigators remain unaware of group assignments throughout the active treatment phase and primary efficacy assessments, eliminating subjective bias in symptom reporting, clinical evaluation, and adverse event recording. The single-dummy design addresses the practical challenge of blinding in TCM-WM combination therapy: all participants receive the identical standard antibiotic regimen (the clinical gold standard for CE), with the experimental group receiving Fuke Qianjin Capsule and the control group receiving a matched placebo of Fuke Qianjin Capsule (identical in appearance, dosage form, administration frequency, and taste). This design maintains the integrity of blinding while ensuring that all participants receive the standard of care antibiotic treatment, upholding ethical principles of clinical research. The study is planned to be conducted across 10-15 clinical centers in China, a multicenter design that enhances the generalizability of study results by enrolling a diverse cohort of participants from different geographical regions, with varying clinical practices and patient demographics-critical for translating research findings into widespread clinical practice.

The study aims to enroll a total of 300 eligible female participants, with a 1:1 random allocation to the experimental group (150 participants) and the control group (150 participants). Eligibility criteria are strictly defined to ensure the homogeneity of the study cohort and the validity of efficacy and safety assessments: participants must be aged 20 to 40 years (a reproductive age range that aligns with the primary population affected by CE and its reproductive complications), have a confirmed diagnosis of CE via gold-standard diagnostic methods (hysteroscopy with clinical scoring and pathological examination including HE staining and CD138 immunohistochemical staining-the definitive diagnostic marker for CE), conform to the TCM syndrome differentiation of damp-heat complicated by deficiency of both qi and blood (to ensure alignment with the therapeutic indications of Fuke Qianjin Capsule), and have a regular menstrual cycle (21 ≤ cycle ≤ 35 days). A comprehensive set of exclusion criteria is implemented to exclude participants with confounding conditions that may impact study outcomes or pose additional safety risks, including acute genital tract or pelvic infection (to avoid overlapping inflammatory processes), endometrial tuberculosis, gynecological malignancies (e.g., endometrial cancer) or severe endometrial lesions (e.g., hyperplasia, intrauterine adhesion, submucous myoma, polyps), hydrosalpinx or pelvic abscess, severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune or endocrine/metabolic diseases (e.g., systemic lupus erythematosus, diabetes mellitus), mental illnesses that impede follow-up cooperation, pregnancy or lactation (or refusal of contraception during treatment), hypersensitivity to any component of the study drugs (Fuke Qianjin Capsule or doxycycline hyclate), participation in other clinical trials within the previous 3 months, and any other conditions deemed unsuitable for participation by the investigating physician.

All enrolled participants receive the first-line antibiotic therapy for CE: doxycycline hyclate tablets (100mg per tablet), administered orally at a dosage of 1 tablet twice daily for a consecutive 14 days-this short-term antibiotic course targets the bacterial etiology of CE, eliminating the pathogenic microorganisms causing endometrial inflammation. The experimental group is administered Fuke Qianjin Capsule (0.4g per capsule) for a consecutive 56 days, with an oral dosage of 2 capsules three times daily, initiated concurrently with the antibiotic regimen. The control group is administered a matched Fuke Qianjin Capsule placebo for the same 56-day duration and identical dosage, ensuring that the only variable between the two groups is the active TCM component. The 56-day duration of the Fuke Qianjin Capsule/placebo intervention is a deliberate study design choice, tailored to the chronic and recurrent nature of CE: while the 14-day antibiotic course addresses acute bacterial infection, the longer TCM intervention is intended to exert sustained anti-inflammatory effects, repair damaged endometrial tissue, improve the reproductive tract microenvironment, and prevent disease recurrence-addressing the unmet need for long-term disease management in CE. All study medications (Fuke Qianjin Capsule, placebo, and doxycycline hyclate tablets) are provided to participants using standardized drug dispensing and collection procedures to ensure medication adherence. Participants are given diary cards to record medication intake, symptom changes, and concomitant medication use. Research staff perform regular checks to monitor and improve adherence.

The total study timeline for each participant spans approximately 8 months, encompassing three distinct phases: a screening/baseline period (up to 28 days), a 56-day active treatment phase, and a 6-month post-treatment follow-up period. Structured in-person study visits are scheduled at key time points to conduct diagnostic assessments, efficacy evaluations, safety monitoring, and drug management, with additional post-treatment follow-up conducted via outpatient visit or telephone to capture long-term outcomes-particularly reproductive outcomes, which are the primary patient-centric endpoints for the target population. The screening/baseline period (Visit 1: Day -28 to 0) involves a comprehensive set of assessments to confirm eligibility: signed informed consent, collection of demographic and clinical data (including medical history, medication history, and reproductive history), gold-standard CE diagnosis (hysteroscopy and pathological examination), TCM syndrome scoring, routine gynecological examinations (vaginal discharge routine), color Doppler ultrasound, and comprehensive safety monitoring (vital signs, blood routine, blood biochemistry, blood pregnancy test). Eligible participants are then randomly assigned to the experimental or control group, with study drugs and diary cards dispensed, and follow-up visits scheduled. During the active treatment phase, two in-person visits are conducted: Visit 2 (Day 28 ± 5 of medication) includes TCM syndrome scoring, color Doppler ultrasound (with supplementary examination if the menstrual clean-up window is missed), safety monitoring, recording of concomitant medications and adverse events, and collection of residual drugs and diary cards; Visit 3 (Day 56 ± 7 of medication)-the end of the active tr

• Change in CD138-positive Plasma Cell Count Before and After Treatment [Срок оценки: Baseline and 56 days after initiation of treatment]
• Traditional Chinese Medicine Syndrome Response Rate at 28 and 56 Days of Treatment [Срок оценки: 28 days and 56 days after initiation of treatment]
• Change in Ultrasound Indexes Before and After Treatment [Срок оценки: Baseline and 56 days after initiation of treatment]
• Clinical Pregnancy Rate After Treatment for Chronic Endometritis [Срок оценки: 6 months after the end of treatment]