Abnormal Uterine Bleeding
Conditions
Interventions
None listed
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18–55years (inclusive). 2.Diagnosis: Meets Western diagnostic criteria for AUB-P AUB-A AUB-L AUB-O or AUB-E (confirmed by endometrial micropathology via diagnostic curettage within the past 6 months) as per the Guidelines for Diagnosis and Treatment of Abnormal Uterine Bleeding (2022). 3.The manifestation of abnormal uterine bleeding is menorrhagia (with significantly increased menstrual flow in 3 or more previous menstrual cycles) accompanied by or without prolonged menstrual periods. 4.Regular menstrual cycles in daily life (in comparison with one's own cycle any change within 7 days is considered consistent). 5.TCM Pattern: Conforms to the Traditional Chinese Medicine (TCM) diagnostic criteria for "Blood Heat Syndrome". 6.Consent: Willingness to participate voluntarily and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Those classified as category M (with structural changes) according to the "PALM-COEIN" system of FIGO; those classified as categories C I (including those caused by sex hormone drugs etc.) and N (without structural changes); those with AUB-O (ovulatory dysfunction) and irregular menstruation; those with AUB-P (polyp) where endometrial polyps are > 1cm or pathological results suggest malignant lesions; and those with AUB-L (leiomyoma) diagnosed with intramural fibroids (=4cm) or submucosal fibroids. 2.Those with previous diagnostic curettage and pathological examination suggesting atypical endometrial hyperplasia or malignant lesions (for subjects aged 40 years and above without relevant data to support ovulation diagnostic curettage and pathological examination must be completed); or those with abnormal female tumor markers. 3.Those with cervical precancerous lesions or cervical cancer. 4.Those with severe concurrent diseases of the heart liver kidneys blood system etc. and deemed by the researcher as unsuitable to participate in this clinical trial; those with abnormal liver or kidney function (ALT or AST > 1.5 times the upper limit of normal blood urea nitrogen or urea = 1.2 times the upper limit of normal serum creatinine > normal value); and those with low hemoglobin (hemoglobin = 80g/L). 5.Those who have received estrogen or progesterone treatment within the past 3 months or have undergone hormone injection within the past 6 months or have taken traditional Chinese medicines with similar indications or other chemical drugs within the past month; 6.Patients who are currently using thrombin or need to use thrombin during the clinical trial or those with abnormal coagulation function; 7.Those who are breastfeeding suspected of being pregnant or planning to become pregnant within 6 months; 8.Those with a history of alcohol or drug abuse; those who are unable to cooperate (such as those with neurological or mental disorders or those unwilling to cooperate); or those who are currently participating in or have participated in other clinical trials within the past 3 months. 9.Those with an allergic constitution those who are allergic to two or more foods or drugs and/or those who are allergic to the known ingredients of the investigational drug. 10.Patients who are deemed by the researcher as unsuitable for drug treatment or have other factors that make them ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in menstrual blood loss (MBL) from baseline (collected at Visit 1) to Visit 4 assessed using the menstrual pictogram method.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in menstrual blood loss (MBL) at Visits 2, 3, and 5 compared to the baseline period (statistical analysis using the menstrual pictogram method);;Changes in Traditional Chinese Medicine (TCM) syndrome scores at Visits 2 3 4 and 5 compared to baseline.;Changes in Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) scores at Visits 2 3 4 and 5 compared to baseline;The proportion of subjects with prolonged menstrual periods at Visits 2, 3, 4, and 5 whose menstrual length returned to normal (menstrual period = 7 days);; | — |
Countries
China
Contacts
Public ContactTeng Xiuxiang
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed