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

NCT07180563 | Recruiting Phase 1

• 1 other identifier: KY-2024-246
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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to the Department of Gastroenterology for diagnosis and treatment, and those who need to stop the drug will be withdrawn from this study.

Conditions

Chronic Endometritis

Outcome Measures

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

  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.

  One month

Study Arms (2)

At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline

ACTIVE COMPARATOR

At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline

Drug: At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline

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

EXPERIMENTAL

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

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

Interventions

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.

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

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.

At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

Related Publications (7)

• McQueen DB, Bernardi LA, Stephenson MD. Chronic endometritis in women with recurrent early pregnancy loss and/or fetal demise. Fertil Steril. 2014 Apr;101(4):1026-30. doi: 10.1016/j.fertnstert.2013.12.031. Epub 2014 Jan 23.

  PMID: 24462055 RESULT

• Cicinelli E, Matteo M, Tinelli R, Lepera A, Alfonso R, Indraccolo U, Marrocchella S, Greco P, Resta L. Prevalence of chronic endometritis in repeated unexplained implantation failure and the IVF success rate after antibiotic therapy. Hum Reprod. 2015 Feb;30(2):323-30. doi: 10.1093/humrep/deu292. Epub 2014 Nov 10.

  PMID: 25385744 RESULT

• Hirata K, Kimura F, Nakamura A, Kitazawa J, Morimune A, Hanada T, Takebayashi A, Takashima A, Amano T, Tsuji S, Kaku S, Kushima R, Murakami T. Histological diagnostic criterion for chronic endometritis based on the clinical outcome. BMC Womens Health. 2021 Mar 4;21(1):94. doi: 10.1186/s12905-021-01239-y.

  PMID: 33663485 RESULT

• Chen YX, Gao QY, Zou TH, Wang BM, Liu SD, Sheng JQ, Ren JL, Zou XP, Liu ZJ, Song YY, Xiao B, Sun XM, Dou XT, Cao HL, Yang XN, Li N, Kang Q, Zhu W, Xu HZ, Chen HM, Cao XC, Fang JY. Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):267-275. doi: 10.1016/S2468-1253(19)30409-1. Epub 2020 Jan 8.

  PMID: 31926918 RESULT

• Shakeri F, Kiani S, Rahimi G, Boskabady MH. Anti-inflammatory, antioxidant, and immunomodulatory effects of Berberis vulgaris and its constituent berberine, experimental and clinical, a review. Phytother Res. 2024 Apr;38(4):1882-1902. doi: 10.1002/ptr.8077. Epub 2024 Feb 15.

  PMID: 38358731 RESULT

• Kuroda K, Takamizawa S, Motoyama H, Tsutsumi R, Sugiyama R, Nakagawa K, Sugiyama R, Kuribayashi Y. Analysis of the therapeutic effects of hysteroscopic polypectomy with and without doxycycline treatment on chronic endometritis with endometrial polyps. Am J Reprod Immunol. 2021 Jun;85(6):e13392. doi: 10.1111/aji.13392. Epub 2021 Jan 27.

  PMID: 33501741 RESULT

• Singh N, Sethi A. Endometritis - Diagnosis,Treatment and its impact on fertility - A Scoping Review. JBRA Assist Reprod. 2022 Aug 4;26(3):538-546. doi: 10.5935/1518-0557.20220015.

  PMID: 35621273 RESULT

MeSH Terms

Interventions

Doxycycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Hu Rubing

CONTACT

+86-13625795941; ificecream@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: September 18, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-03

Locations

CN (1)