Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）

DongE E Jiao Coporation Limited

Status and phase

Not yet enrolling

Phase 4

Conditions

Postpartum Anemia

Treatments

Drug: compound E Jiao Jiang(cEJJ) placebo

Drug: compound E Jiao Jiang(cEJJ)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06175117

DEEJ-CTP-20230724

Details and patient eligibility

About

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 effectiveness of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.

To evaluate the safety of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.

To explore the effect of compound ejiao decoction on improving anxiety, depression, sleep and fatigue in postpartum anemia patients.

Participants will be randomly assigned (like flipping a coin) to either the trial group or the control group (with a 50% chance of being assigned to either group), where the trial group will receive the compound E Jiao Jiang(cEJJ） + ferrous succinate tablet, and the control group will receive the compound E Jiao Jiang(cEJJ）placebo + ferrous succinate tablet. The compound E Jiao Jiang(cEJJ）placebo is the same/similar to the compound E Jiao Jiang(cEJJ） in terms of appearance, smell and taste, but has no therapeutic effect.And participants need to return to the research center on time for relevant examinations according to the protocol requirements.

Enrollment

360 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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);
People with a history of alcoholism, drug abuse, or drug abuse;
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.