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

Phase 4

Not yet recruiting

• Conditions: Postpartum Anemia
• Interventions: Drug: compound E Jiao Jiang(cEJJ); Drug: compound E Jiao Jiang(cEJJ) placebo

• Registration Number: NCT06175117
• Lead Sponsor: DongE E Jiao Coporation Limited

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-27
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compound E Jiao Jiang(cEJJ)	compound E Jiao Jiang(cEJJ)	20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.
compound E Jiao Jiang(cEJJ) placebo	compound E Jiao Jiang(cEJJ) placebo	20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.

Primary Outcome Measures

Name	Time	Method
Hemoglobin（Hb） change value	6 weeks	Hb changes after 6 weeks of continuous medication

Secondary Outcome Measures

Name	Time	Method
serum iron change value	6 weeks	serum iron changes after 6 weeks of continuous medication
The proportion of hemoglobin returned to normal	6 weeks	Hb returned to normal proportions after 6 weeks of continuous medication
Red Blood Cell（RBC） change value	6 weeks	RBC changes after 6 weeks of continuous medication
The proportion of hemoglobin rising > 20g/L	6 weeks	The proportion of Hb increased \>20g/L after 6 weeks of continuous administration
serum ferritin change value	6 weeks	serum ferritin changes after 6 weeks of continuous medication
The proportion of hemoglobin rising > 10g/L	6 weeks	The proportion of Hb increased \>10g/L after 6 weeks of continuous administration
Hematocrit（HCT ）change value	6 weeks	HCT changes after 6 weeks of continuous medication
Traditional Chinese Medicine symptom score（a self-made scale for Qi-blood Deficiency Syndrome） change value	6 weeks	The TCM Qi and blood deficiency scale total score ranges from 0 to 54, and the higher the score, the more serious it is.