Berberine plus doxycycline versus doxycycline alone for chronic endometritis
Official title: Randomized Controlled Trial of Berberine in Combination With Doxycycline in the Treatment of Chronic Endometritis
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07180563 · Data updated 2026-11-12
This trial tests whether adding berberine to standard doxycycline helps women of childbearing age with chronic endometritis diagnosed by CD138 to become cured more often.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | Women only |
| Enrollment | 206 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Status | Recruiting |
| Started | March 15, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT07180563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20 or older of childbearing age with CD138-confirmed chronic endometritis who can undergo hysteroscopy and have no contraindications to doxycycline or berberine are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have uterine malignancy, recent hormone therapy, G6PD deficiency, hemolytic anemia, hypersensitivity to the study drugs, or serious systemic disease are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label Phase 1/2 trial randomly assigns women diagnosed with CD138-positive chronic endometritis to receive either doxycycline alone or doxycycline plus oral berberine for 14 days. Diagnosis and outcome assessment rely on hysteroscopy with endometrial biopsy and CD138 immunohistochemistry, with cure defined as conversion from CD138-positive to negative. Primary outcome is cure rate; secondary outcomes include the number of CD138-positive plasma cells per 10 high-power fields and rates and characteristics of recurrent uterine polyps. Treatment allocation is 1:1 and patients are followed after a single treatment course to compare response and recurrence.
Why it matters
Potential benefit: If successful, combining berberine with doxycycline could increase cure rates and reduce recurrence of chronic endometritis, potentially improving reproductive outcomes for affected women.
How similar studies have gone: Doxycycline is an established treatment for chronic endometritis, while adding berberine is a relatively novel approach with limited prior clinical data supporting its use in this condition.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Hu Rubing
- Email: ificecream@sina.com
- Phone: +86-13625795941
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.