FuKe Qianjin Capsule Plus Antibiotics for Chronic Endometritis

NCT07485842 | Not Yet Recruiting Phase 4

• 1 other identifier: FKQJCE-2026-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Endometritis

Keywords

Chronic Endometritis; Clinical efficacy and safety; Combination Drug Therapy; Multicenter Clinical Studies; Fuke Qianjin Capsule

Outcome Measures

Primary Outcomes (1)

• Clinical Efficacy Rate After 56 Days of Treatment for Chronic Endometritis

  To compare the clinical efficacy rate between the two groups following 56 days of treatment for chronic endometritis

  56 days after initiation of treatment

Secondary Outcomes (4)

• Change in CD138-positive Plasma Cell Count Before and After Treatment

  Baseline and 56 days after initiation of treatment

• Traditional Chinese Medicine Syndrome Response Rate at 28 and 56 Days of Treatment

  28 days and 56 days after initiation of treatment

• Change in Ultrasound Indexes Before and After Treatment

  Baseline and 56 days after initiation of treatment

• Clinical Pregnancy Rate After Treatment for Chronic Endometritis

  6 months after the end of treatment

Study Arms (2)

Antibiotics plus FuKe Qianjin Capsules

EXPERIMENTAL

14 consecutive days of doxycycline hyclate tablets combined with 56 days of FuKe Qianjin Capsule. FuKe 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.

Drug: FuKe Qianjin Capsules

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. FuKe 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.

Drug: FuKe Qianjin Capsules

Interventions

FuKe Qianjin Capsules DRUG

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/its 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.

Antibiotics plus FuKe Qianjin Capsules; Antibiotics plus a matching FuKe Qianjin Capsule placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range: 20 years old ≤ age ≤ 40 years old;
• Meets the diagnostic criteria for chronic endometritis;
• Meets the Traditional Chinese Medicine(TCM) syndrome differentiation criteria for damp-heat with deficiency of both qi and blood;
• Has a regular menstrual cycle, with a cycle length ≥21 days and ≤35 days;
• Voluntarily participates and signs the informed consent form.

You may not qualify if:

• Patients with concurrent acute genital tract and pelvic infections, etc.
• Patients with endometrial tuberculosis, endometrial cancer, or other malignant gynecological tumors.
• Patients with endometrial lesions, such as endometrial hyperplasia, uterine cavity adhesions, submucosal fibroids, or endometrial polyps.
• Patients with hydrosalpinx or pelvic abscesses.
• Patients with severe abnormalities in heart, liver, or kidney function.
• Patients with uncontrolled autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, etc.).
• Patients with uncontrolled endocrine or metabolic diseases (e.g., diabetes, hyperthyroidism, or hypothyroidism, etc.).
• Patients with mental disorders (e.g., severe depression, schizophrenia) or unable to comply with follow-up.
• Pregnant or breastfeeding women, or those refusing contraception during treatment.
• Patients with allergies to study drugs (including Chinese herbal components or antibiotics).
• Patients who have participated in other clinical trials within the past 3 months.
• Other situations where the investigator deems the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Tianjin Medical University: lead
• Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China: collaborator

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Publications (5)

• Cicinelli E, Vitagliano A, Kumar A, Lasmar RB, Bettocchi S, Haimovich S; International Working Group for Standardization of Chronic Endometritis Diagnosis. Unified diagnostic criteria for chronic endometritis at fluid hysteroscopy: proposal and reliability evaluation through an international randomized-controlled observer study. Fertil Steril. 2019 Jul;112(1):162-173.e2. doi: 10.1016/j.fertnstert.2019.03.004. Epub 2019 May 16.

  PMID: 31104760 BACKGROUND

• Jie P, Kai-Ni Z, Xiao-Mei W, Meng-Pei Z, Zhi-Heng W, Hao-Xiang Z, Wen-Tao Z. Systematic Review and Meta-Analysis of Randomized Controlled Trials of Fuke Qianjin Tablet. Evid Based Complement Alternat Med. 2021 Feb 17;2021:8861631. doi: 10.1155/2021/8861631. eCollection 2021.

  PMID: 33680066 BACKGROUND

• Xiong S, Xu C, Yang C, Luo H, Xie J, Xia B, Zhang Z, Liao Y, Li C, Li Y, Lin L. FuKe QianJin capsule alleviates endometritis via inhibiting inflammation and pyroptosis through modulating TLR4/ NF-kappaB /NLRP3 pathway. J Ethnopharmacol. 2025 Jan 30;337(Pt 3):118962. doi: 10.1016/j.jep.2024.118962. Epub 2024 Oct 18.

  PMID: 39426577 BACKGROUND

• McQueen DB, Bernardi LA, Stephenson MD. Chronic endometritis in women with recurrent early pregnancy loss and/or fetal demise. Fertil Steril. 2014 Apr;101(4):1026-30. doi: 10.1016/j.fertnstert.2013.12.031. Epub 2014 Jan 23.

  PMID: 24462055 BACKGROUND

• Cicinelli E, Matteo M, Tinelli R, Lepera A, Alfonso R, Indraccolo U, Marrocchella S, Greco P, Resta L. Prevalence of chronic endometritis in repeated unexplained implantation failure and the IVF success rate after antibiotic therapy. Hum Reprod. 2015 Feb;30(2):323-30. doi: 10.1093/humrep/deu292. Epub 2014 Nov 10.

  PMID: 25385744 BACKGROUND

Central Study Contacts

Fengxia Xue

CONTACT

+86 13902071517; lvyohu@163.com

Wenyan Tian

CONTACT

tianwenyan1108@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)