Actively Recruiting

Phase 1
Phase 2
Age: 20Years +
FEMALE
NCT07180563

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

Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-09-18

206

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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to the Department of Gastroenterology for diagnosis and treatment, and those who need to stop the drug will be withdrawn from this study.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

Official Title

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

Who Can Participate

Age: 20Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of chronic endometritis by CD138 immunohistochemistry
  • Female aged 20 years or older of childbearing age
  • Agree to undergo hysteroscopy and hysteroscopic endometrial biopsy
  • No serious systemic disease
  • No contraindications to oral doxycycline hydrochloride and berberine hydrochloride
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Patients with uterine malignant disease
  • Received hormone therapy within 3 months
  • Glucose-6 phosphate dehydrogenase deficiency
  • Hemolytic anemia
  • Hypersensitivity to berberine hydrochloride or doxycycline
  • Patients who have taken medication incorrectly or missed doses

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China, 322000

Actively Recruiting

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Research Team

H

Hu Rubing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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