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Randomized Controlled Trial of Berberine in Combination With Doxycycline in the Treatment of Chronic Endometritis

NCT07180563 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2025-09-18

No results posted yet for this study

Summary

Study Subjects: Eligible patients were initially diagnosed with chronic endometritis (CE) by CD138 testing through outpatient hysteroscopy. Positive CD138 expression is defined as at least one or more positive-staining plasma cells per 10 high-power fields identified as positive, and less than one positive-stained plasma cell identified as negative \[8\]. All patients signed an informed consent form prior to participating in the study, and the study followed the principles of the Declaration of Helsinki.

Inclusion Criteria: Diagnosis of chronic endometritis by CD138 immunohistochemistry; Age≥ 20 years old, females of childbearing age; Agree to undergo hysteroscopy and hysteroscopic endometrial biopsy; No serious systemic disease; There are no contraindications to oral administration of doxycycline hydrochloride and berberine hydrochloride.

Exclusion criteria: patients with pregnancy status, uterine malignant disease, hormone therapy within 3 months, glucose-6 phosphate dehydrogenase deficiency, hemolytic anemia, hypersensitivity to berberine hydrochloride or doxycycline. In addition, berberine hydrochloride has fewer oral adverse reactions, occasional nausea and vomiting, rash and drug fever, which disappear after stopping the drug. If the patient takes the wrong or missed medication, it is excluded.

Withdrawal criteria: If the patient has corresponding adverse reaction symptoms, those with mild symptoms can be temporarily observed, and if the symptoms are severe, they can be transferred to the Department of Gastroenterology for diagnosis and treatment, and those who need to stop the drug will be withdrawn from this study.

Conditions

  • Chronic Endometritis

Interventions

DRUG

Participants were treated with doxycycline + berberin for chronic endometritis (intervention group).

Diagnosed chronic endometritis according to endometrial biopsy pathology , the specific medication plan for the intervention group was to use doxycycline 100mg, bid + berberin 100mg, tid, continuously for 14 days.

DRUG

At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline

11After hysteroscopic diagnosis of chronic endometritis, patients received monotherapy with doxycycline hydrochloride capsules for 14 days.

Sponsors & Collaborators

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07180563 on ClinicalTrials.gov