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Efficacy and safety of fresh motherwort capsule in treatment of AUB-E (blood stasis syndrome): a randomized, double-blind, positive drug parallel control, multicenter clinical trial

Efficacy and safety of fresh motherwort capsule in treatment of AUB-E (blood stasis syndrome): a randomized, double-blind, positive drug parallel control, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027477
Enrollment
Unknown
Registered
2019-11-15
Start date
2019-11-28
Completion date
Unknown
Last updated
2020-11-16

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

Conditions

Abnormal uterine bleeding AUB-E (stagnation of blood )

Interventions

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. In line with western medicine abnormal uterine bleeding diagnostic criteria,be classified asAUB-E 2. According to the traditional Chinese medicine diagnostic standard of prolonged menstrual period, syndrome differentiation of traditional Chinese medicine is blood stasis syndrome. 3. Those aged between 18 and 45 years old (including 18 and 45 years old) with regular menstrual cycle and prolonged menstrual period for 3 consecutive months; 4. The menstrual period is 7 days > and <= 14 days; 5. Subject will sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Allergy, mental illness, drug or alcohol abuse or drug addiction 2. The examination showed organic lesions, such as uterine fibroids (diameter >= 3cm), endometrial polyps (diameter > 1cm), pituitary tumors, adenomyosis, submucosal fibroids, scar defects after cesarean section, 3. Abnormal uterine bleeding AUB-O 4. Prolonged menstrual period caused by ectopic pregnancy, pregnancy complications, intrauterine contraceptive device, trauma, endometritis, pelvic inflammatory disease and other hemorrhagic diseases; 5. Suspicious or confirmed thrombocytopenia and other coagulation mechanism disorders, hyperthyroidism or hypothyroidism and other hemorrhagic diseases that cause abnormal uterine bleeding; 6. Combined with liver and kidney function impairment, ALT, AST > normal value upper limit, or Cr > normal value upper limit;Combined with hematopoietic system and other serious primary diseases 7. Those who have been treated with other traditional Chinese medicine or participated in other clinical trials in the past month; 8. Received hormone and other western medicine treatment or hysteroscopic surgery, abortion and other uterine operators within the last 3 months; 9. Planned pregnancy and lactation; 10. According to the judgment of the researcher, other lesions or conditions that may reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.

Design outcomes

Primary

MeasureTime frame
blood routine examination;routine urine test;ALT;AST;ALP;GGT;TBIL;BUN;Cr;Four coagulation;gynecologic examination;HCG;Transvaginal or transrectal ultrasound;12-lead ecg;

Countries

CHINA

Contacts

Public ContactYun Shi

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

zysyun@163.com+86 13717926522

Outcome results

None listed

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