A randomized controlled trial for the Bu-Xue Yi-Mu particles in the treatment of postpartum disease

Phase 4

• Conditions: Postpartum disease (e.g., postpartum anemia, postpartum lochia, postpartum abdominal pain, Postpartum uterine instauration, postpartum pelvic floor repair, etc.)

• Registration Number: ITMCTR1900002835
• Lead Sponsor: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects' informed consent to participate voluntarily, and signed informed consent in person or by legal guardian;
2. Aged 20-40 years;
3. Maternity or cesarean delivery: 37 weeks-41 weeks + 6 days;
4. Hemoglobin is greater than 90 g/L and less than 105 g/L.

Exclusion Criteria

1. Patients with severe medical comorbidities (heart disease, liver disease, kidney disease, etc.) have abnormal liver and kidney function; or the value of alanine aminotransferase (ALT) or or aspartate aminotransferase (AST) >2 ULN;
Those: or those whose creatinine (Cr) is greater than the upper limit of normal value;
2. People with severe endocrine diseases (pre-pregnancy diabetes, hyperthyroidism, etc.);
3. those with pregnancy-induced hypertension and sepsis;
4. Reproductive tract malformations and uterine infections;
5. Placenta implantation or dangerous placenta previa;
6. Those who have failed the trial and transferred to cesarean section;
7. >=2 abdominal operations related to the uterus and >=4 deliveries;
8. those with severe coagulopathy or whose PT and or APTT values ??exceed the upper limit of normal values; or
Those with platelets less than 80x10^9/L;
9. Uterine fibroids: single fibroids >=5cm; or multiple fibroids> 3, single fibroids >=2cm;
10. Those with a history of adenomyoma before pregnancy;
11. Multiple pregnancy;
12. Subjects who are taking HIV protease inhibitors;
13. Those who are allergic to the test drug;
14. Participated in other clinical researchers within three months before enrollment;
15. Researchers do not consider it appropriate to participate in this trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic floor recovery test;Visual Analogue Scale (VAS) Pain Score;blood routine;haemoglobin;Coagulation test;lochia;Obstetrics and gynecology ultrasound;