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

NCT06175117 | Completed Phase 4

• 1 other identifier: DEEJ-CTP-20230724
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Anemia

Outcome Measures

Primary Outcomes (1)

• Hemoglobin（Hb） change value

  Hb changes after 6 weeks of continuous medication

  6 weeks

Secondary Outcomes (8)

• The proportion of hemoglobin returned to normal

  6 weeks

• The proportion of hemoglobin rising > 20g/L

  6 weeks

• The proportion of hemoglobin rising > 10g/L

  6 weeks

• serum iron change value

  6 weeks

• serum ferritin change value

  6 weeks

Other Outcomes (4)

• Edinburgh Postnatal Depression（EPDS） change value

  6 weeks

• Self-rating Anxiety Scale（SAS）change value

  6 weeks

• Pittsburgh sleep quality index（PSQI） change value

  6 weeks

Study Arms (2)

compound E Jiao Jiang(cEJJ)

EXPERIMENTAL

20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.

Drug: compound E Jiao Jiang(cEJJ)

compound E Jiao Jiang(cEJJ) placebo

PLACEBO COMPARATOR

20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.

Drug: compound E Jiao Jiang(cEJJ) placebo

Interventions

compound E Jiao Jiang(cEJJ) DRUG

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

Also known as: ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）

compound E Jiao Jiang(cEJJ)

compound E Jiao Jiang(cEJJ) placebo DRUG

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.

Also known as: ferrous succinate tablet（1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.）

compound E Jiao Jiang(cEJJ) placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DongE E Jiao Coporation Limited: lead

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityBeijing Maternal and Child Health Care Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 18, 2023
• Study Start: January 7, 2023
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)