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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20+
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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to the Department of Gastroenterology for diagnosis and treatment, and those who need to stop the drug will be withdrawn from this study.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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Drug

    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

    Drug

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

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: At present, the commonly used clinical treatment for chronic endometritis is oral doxycyclineActive comparator 1 intervention
Group B: Participants were treated with doxycycline + berberin for chronic endometritis (intervention group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patients in both groups started taking antibiotics after being diagnosed with chronic endometritis by CD138 testing. After a course of treatment, the conversion rate of chronic endometritis expression from positive to negative was compared between the tw

Time frame
One month

Secondary outcomes

1

Number of CD138 positives per 10 high-power fields; recurrence rate of uterine polyps; Number and size of recurrence of uterine polyps.

Time frame
One month

Other outcomes

Sponsors and contacts

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