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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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to the Department of Gastroenterology for diagnosis and treatment, and those who need to stop the drug will be withdrawn from this study.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
Participation Requirements
Sex: Female
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Yiwu
Contact Information
Primary
Hu Rubing
ificecream@sina.com
+86-13625795941
Time Frame
Start Date: 2025-03-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 206
Treatments
Active_comparator: At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline
At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline
Experimental: Participants were treated with doxycycline + berberin for chronic endometritis (intervention group)
Participants were treated with doxycycline + berberin for chronic endometritis (intervention group)
Sponsors
Leads: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov