Clinical trial NCT06175117: Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Compound E Jiao Jiang(cEJJ）in the Treatment of Postpartum Anemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postpartum Anemia
Lead sponsor: DongE E Jiao Coporation Limited
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with mild or moderate anemia (70g/L≤Hb \< 110g/L) within 1 week postpartum and suitable for oral drug therapy;
2. Age 18-45 years old (including 18 and 45);
3. 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;
4. Sign the subject's informed consent voluntarily.

Exclusion Criteria:

1. Postpartum hemorrhage and blood transfusion treatment;
2. 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;
3. Patients who have taken blood tonics within 1 week before screening, including other iron preparations and Chinese medicine or Chinese medicine preparations;
4. People with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia;
5. Severe preeclampsia during pregnancy;
6. Abortion occurs in this pregnancy;
7. 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;
8. Severe hepatic and renal insufficiency (ALT \>2×ULN, aspartate aminotransferase (AST)\>2×ULN, Urea (Urea)/ urea nitrogen (BUN)\>2×ULN, creatinine (Cr)\>1×ULN);
9. People with a history of alcoholism, drug abuse, or drug abuse;
10. Allergic to the experimental drug or known ingredient;
11. Participants who had participated in other clinical trials within 3 months before screening;
12. Those who, according to the judgment of the investigator, consider it inappropriate to participate in this clinical trial.

Primary outcomes:
measure: Hemoglobin（Hb） change value
timeFrame: 6 weeks
Secondary outcomes:
measure: The proportion of hemoglobin returned to normal
timeFrame: 6 weeks
measure: The proportion of hemoglobin rising > 20g/L
timeFrame: 6 weeks
measure: The proportion of hemoglobin rising > 10g/L
timeFrame: 6 weeks
measure: serum iron change value
timeFrame: 6 weeks
measure: serum ferritin change value
timeFrame: 6 weeks
measure: Red Blood Cell（RBC） change value
timeFrame: 6 weeks
measure: Hematocrit（HCT ）change value
timeFrame: 6 weeks
measure: Traditional Chinese Medicine symptom score（a self-made scale for Qi-blood Deficiency Syndrome） change value
timeFrame: 6 weeks
Other outcomes:
measure: Edinburgh Postnatal Depression（EPDS） change value
timeFrame: 6 weeks
measure: Self-rating Anxiety Scale（SAS）change value
timeFrame: 6 weeks
measure: Pittsburgh sleep quality index（PSQI） change value
timeFrame: 6 weeks
measure: The Functional Assessment of Chronic Illness Therapy-Fatigue（FACIT-F） change value
timeFrame: 6 weeks
Locations:
Study officials:
References: