Chronic EndometritisPhase 1/2NCT07180563
Randomized Controlled Trial of Berberine in Combination With Doxycycline in the Treatment of Chronic Endometritis
A Phase 1/2 study testing Participants were treated with doxycycline + berberin for chronic endometritis (intervention group). and At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline in people with Chronic Endometritis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Chronic Endometritis
- What is being tested?
- Participants were treated with doxycycline + berberin for chronic endometritis (intervention group). and At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
rubing hu, +86 13625795941, ficecream@sina.com
About this study
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.
Read more
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.
Read the detailed description
Grouping: The patients were randomly divided into the experimental group and the control group by a simple numerical table method, with a ratio of 1:1.
- Patients in the experimental group were treated with berberine hydrochloride tablets (0.1g*100 tablets/bottle, Shenyang First Pharmaceutical Co., Ltd., Northeast Pharmaceutical Group) + doxycycline hydrochloride capsules (100mg*24 tablets/box, Guangzhou Percello Pharmaceutical Co., Ltd.), with oral administration of berberine hydrochloride tablets 100mg Tid per day and oral administration of doxycycline hydrochloride capsules 100mg Bid per day for 14 days.
- Patients in the control group were treated with oral doxycycline hydrochloride capsules only and oral doxycycline hydrochloride capsules 100 mg twice a day for 14 days.
Evaluation indicators: Patients in both groups started taking antibiotics after being diagnosed with chronic endometritis by CD138 detection. After a course of treatment, the conversion rate of chronic endometritis expression from positive to negative was compared between the two groups.
Outcomes: Primary outcomes: Cure rate of chronic endometritis; Secondary outcomes: Number of CD138 positives per 10 high-power fields; Recurrence rate of uterine polyps, number and size of uterine polyps recurrence.
- Conditions
- Chronic Endometritis
- Being tested
- Participants were treated with doxycycline + berberin for chronic endometritis (intervention group)., At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 doxycyclineDrug
11After hysteroscopic diagnosis of chronic endometritis, patients received monotherapy with doxycycline hydrochloride capsules for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Participants were treated with doxycycline + berberin for chronic endometritis (intervention group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic EndometritisStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180563
- Sponsor's protocol ID
- KY-2024-246
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24462055Cicinelli 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.
PubMed 25385744Hirata 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.
PubMed 33663485Chen 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.
PubMed 31926918Shakeri 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.
PubMed 38358731Kuroda 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.
PubMed 33501741Singh 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.
PubMed 35621273
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Berberine in Combination With Doxycycline in the Treatment of Chronic Endometritis
- ClinicalTrials.gov ID
- NCT07180563
- Acronym / sponsor ID
- KY-2024-246
- Conditions
- Chronic Endometritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Grouping: The patients were randomly divided into the experimental group and the control group by a simple numerical table method, with a ratio of 1:1.
- Patients in the experimental group were treated with berberine hydrochloride tablets (0.1g*100 tablets/bottle, Shenyang First Pharmaceutical Co., Ltd., Northeast Pharmaceutical Group) + doxycycline hydrochloride capsules (100mg*24 tablets/box, Guangzhou Percello Pharmaceutical Co., Ltd.), with oral administration of berberine hydrochloride tablets 100mg Tid per day and oral administration of doxycycline hydrochloride capsules 100mg Bid per day for 14 days.
- Patients in the control group were treated with oral doxycycline hydrochloride capsules only and oral doxycycline hydrochloride capsules 100 mg twice a day for 14 days.
Evaluation indicators: Patients in both groups started taking antibiotics after being diagnosed with chronic endometritis by CD138 detection. After a course of treatment, the conversion rate of chronic endometritis expression from positive to negative was compared between the two groups.
Outcomes: Primary outcomes: Cure rate of chronic endometritis; Secondary outcomes: Number of CD138 positives per 10 high-power fields; Recurrence rate of uterine polyps, number and size of uterine polyps recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline | Active comparator | Drug: At present, the commonly used clinical treatment for chronic endometritis is oral doxycyclineAt present, the commonly used clinical treatment for chronic endometritis is oral doxycycline |
| Participants were treated with doxycycline + berberin for chronic endometritis (intervention group) | Experimental | Drug: Participants were treated with doxycycline + berberin for chronic endometritis (intervention group).Participants were treated with doxycycline + berberin for chronic endometritis (intervention group) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants were treated with doxycycline + berberin for chronic endometritis (intervention group).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. | Drug | Participants were treated with doxycycline + berberin for chronic endometritis (intervention group) |
| At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline11After hysteroscopic diagnosis of chronic endometritis, patients received monotherapy with doxycycline hydrochloride capsules for 14 days. | Drug | At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 24462055McQueen 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.
- Results publication: PubMed 25385744Cicinelli 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.
- Results publication: PubMed 33663485Hirata 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.
- Results publication: PubMed 31926918Chen 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.
- Results publication: PubMed 38358731Shakeri 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.
- Results publication: PubMed 33501741Kuroda 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.
- Results publication: PubMed 35621273Singh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Participants were treated with doxycycline + berberin for chronic endometritis (intervention group). and At present, the commonly used clinical treatment for chronic endometritis is oral doxycycline in people with Chronic Endometritis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hu Rubing (+86-13625795941, ificecream@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180563, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.