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Clinical Trials in China / NCT07180563
Recruiting Phase 1/2

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

NCT07180563 · tracked via the Priya Life Science China tracker
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Phase
Phase 1/2
Started
2025-03-15
Last updated
2025-09-18

Condition(s) studied

Chronic Endometritis

Investigational drug(s) / intervention(s)

Participants were treated with doxycycline + berberin for chronic endometritis (intervention group).At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline

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.

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.

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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Fourth Affiliated Hospital of Zhejiang University School of Medicine Yiwu Zhejiang Recruiting

More The Fourth Affiliated Hospital of Zhejiang University School of Medicine trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180563 on ClinicalTrials.gov ↗ ← All trials in China