Status:
COMPLETED
Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）
Lead Sponsor:
DongE E Jiao Coporation Limited
Conditions:
Postpartum Anemia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial\] is to compare the effect of compound E Jiao Jiang(cEJJ）combined with iron decoction on postpartum anemia.The main questions it aims to answer are: To evaluate the ef...
Eligibility Criteria
Inclusion
- Patients diagnosed with mild or moderate anemia (70g/L≤Hb \< 110g/L) within 1 week postpartum and suitable for oral drug therapy;
- Age 18-45 years old (including 18 and 45);
- Those who do not use other iron agents and Chinese medicine/Chinese medicine preparations that have the effect of invigorating qi and nourishing blood during the study;
- Sign the subject's informed consent voluntarily.
Exclusion
- Postpartum hemorrhage and blood transfusion treatment;
- Those who received intramuscular/intravenous iron therapy or transfused blood products/human blood albumin and other plasma volume dilators within 3 months prior to screening;
- Patients who have taken blood tonics within 1 week before screening, including other iron preparations and Chinese medicine or Chinese medicine preparations;
- People with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia;
- Severe preeclampsia during pregnancy;
- Abortion occurs in this pregnancy;
- Patients with a serious digestive disease, cardiovascular disease, immune system disease, or serious mental disorder that the investigator believes may adversely affect the safety of the subject and/or the effectiveness of the investigational drug;
- Severe hepatic and renal insufficiency (ALT \>2×ULN, aspartate aminotransferase (AST)\>2×ULN, Urea (Urea)/ urea nitrogen (BUN)\>2×ULN, creatinine (Cr)\>1×ULN);
- Those who have a history of alcohol abuse, drug abuse or drug use before;
- Allergic to the experimental drug or known ingredient;
- Participants who had participated in other clinical trials within 3 months before screening;
- Those who, according to the judgment of the investigator, consider it inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
January 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06175117
Start Date
January 7 2023
End Date
September 8 2025
Last Update
December 15 2025
Active Locations (1)
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1
Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityBeijing Maternal and Child Health Care Hospital
Beijing, China