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Clinical observation study on the treatment of abnormal uterine bleeding by Gongxuining capsule

Clinical observation study on the treatment of abnormal uterine bleeding by Gongxuining capsule

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076585
Enrollment
Unknown
Registered
2023-10-12
Start date
2023-10-15
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Abnormal uterine bleeding

Interventions

Uterine Blood Ning Capsules Single Drug Group:None

Sponsors

Guangdong Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. those who meet the western medical diagnostic criteria of AUB in the Diagnostic and Therapeutic Guidelines for Abnormal Uterine Bleeding, or those who meet the diagnostic criteria of disintegration in the International Clinical Practice Guidelines for Traditional Chinese Medicine on Disintegration and Leakage, and who have excessive menstruation and/or prolonged menstruation and/or intermenstrual bleeding; 2. age: 18~55 years old; 3. good compliance; 4. subjects understood and participated voluntarily and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with a combination of severe heart disease and serious diseases of the blood system, malignant tumors, psychiatric patients, abnormal liver and kidney functions (liver transaminases > 1.5 times the upper limit of normal, blood urea nitrogen and serum creatinine > 1.2 times the upper limit of normal); 2. AUB due to systemic coagulation-related diseases (AUB-C) and endometrial malignancy and atypical hyperplasia (AUB-M); 3. abnormal vaginal bleeding during or associated with pregnancy; 4. abnormal uterine bleeding caused by intrauterine devices, etc; 5. those with hemoglobin = 80g/L; 6. those who have participated in other clinical trials in the last 3 months; 7. those who have undergone diagnostic scraping within the last 1 month or those who intend to undergo diagnostic scraping during the study period; 8. those who have used proprietary Chinese medicines, herbal medicines and tonics with hemostatic effect within 1 month; 9. patients who, in the judgment of the investigator, are not suitable for drug treatment or have other unsuitable factors for enrollment.

Design outcomes

Primary

MeasureTime frame
Changes in menstrual bleeding after treatment;Changes in quality of life scores after treatment;Post-treatment changes in menstrual length;Changes in the number of days of intermenstrual bleeding after treatment;Recurrence rate of menstruation;Security Observation;

Countries

China

Contacts

Public ContactLiang Xuefang

Gynecology, Guangdong Hospital of Traditional Chinese Medicine

liangxuefang@126.com+86 139 2608 2916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026