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A Randomized, Double-Blind, Single-Simulation, Multicenter Clinical Study Evaluating the Efficacy and Safety of Gynecological Qianjin Capsules in Combination with Antibiotics for the Treatment of Chronic Endometritis.

A Randomized, Double-Blind, Single-Simulation, Multicenter Clinical Study Evaluating the Efficacy and Safety of Gynecological Qianjin Capsules in Combination with Antibiotics for the Treatment of Chronic Endometritis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000526
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic endometritis

Interventions

Experimental Group:Doxycycline Hyclate Tablets + Qianjin Gynecological Capsules
Control Group:Doxycycline hydrochloride tablets + Gynecological Qianjin capsule simulator

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 20 years old = age = 40 years old; 2. Meets the diagnostic criteria for chronic endometritis; 3. Meets the TCM syndrome differentiation criteria for damp-heat with deficiency of both qi and blood; 4. Has a regular menstrual cycle, with a cycle length =21 days and =35 days; 5. Voluntarily participates and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with concurrent acute genital tract and pelvic infections, etc. 2. Patients with endometrial tuberculosis, endometrial cancer, or other malignant gynecological tumors. 3. Patients with endometrial lesions, such as endometrial hyperplasia, uterine cavity adhesions, submucosal fibroids, or endometrial polyps. 4. Patients with hydrosalpinx or pelvic abscesses. 5. Patients with severe abnormalities in heart, liver, or kidney function. 6. Patients with uncontrolled autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, etc.). 7. Patients with uncontrolled endocrine or metabolic diseases (e.g., diabetes, hyperthyroidism, or hypothyroidism, etc.). 8. Patients with mental disorders (e.g., severe depression, schizophrenia) or unable to comply with follow-up. 9. Pregnant or breastfeeding women, or those refusing contraception during treatment. 10. Patients with allergies to study drugs (including Chinese herbal components or antibiotics). 11. Patients who have participated in other clinical trials within the past 3 months. 12. Other situations where the investigator deems the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
The clinical efficacy rate after treatment for chronic endometritis for 56 days.;

Secondary

MeasureTime frame
Changes in the number of CD138-positive plasma cells before and after treatment.;Efficacy rate of Traditional Chinese Medicine (TCM) syndromes after 28 and 56 days of treatment.;The changes in color Doppler ultrasound indices before and after treatment.;The clinical pregnancy rate after treatment for chronic endometritis.;

Countries

China

Contacts

Public ContactXue Fengxia

Tianjin Medical University General Hospital

xuefengxia@tmu.edu.cn15922125459

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026