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Completed

NCT Number: NCT06175117

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);
  • 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.

Treatment and study plan

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.

Other names: 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

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.

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

Primary outcomes

  1. Hemoglobin(Hb) change value

    Time frame: 6 weeks

    Hb changes after 6 weeks of continuous medication

Secondary outcomes

  1. The proportion of hemoglobin returned to normal

    Time frame: 6 weeks

    Hb returned to normal proportions after 6 weeks of continuous medication

  2. The proportion of hemoglobin rising > 20g/L

    Time frame: 6 weeks

    The proportion of Hb increased >20g/L after 6 weeks of continuous administration

  3. The proportion of hemoglobin rising > 10g/L

    Time frame: 6 weeks

    The proportion of Hb increased >10g/L after 6 weeks of continuous administration

  4. serum iron change value

    Time frame: 6 weeks

    serum iron changes after 6 weeks of continuous medication

  5. serum ferritin change value

    Time frame: 6 weeks

    serum ferritin changes after 6 weeks of continuous medication

  6. Red Blood Cell(RBC) change value

    Time frame: 6 weeks

    RBC changes after 6 weeks of continuous medication

  7. Hematocrit(HCT )change value

    Time frame: 6 weeks

    HCT changes after 6 weeks of continuous medication

  8. Traditional Chinese Medicine symptom score(a self-made scale for Qi-blood Deficiency Syndrome) change value

    Time frame: 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.

Other outcomes

  1. Edinburgh Postnatal Depression(EPDS) change value

    Time frame: 6 weeks

    The EPDS total score ranges from 0 to 30, and the higher the score, the severe the depression.

  2. Self-rating Anxiety Scale(SAS)change value

    Time frame: 6 weeks

    The SAS total score ranges from 0 to 80, and the higher the score, the greater the anxiety.

  3. Pittsburgh sleep quality index(PSQI) change value

    Time frame: 6 weeks

    The PSQI total score ranges from 0 to 21, and the higher the score, the worse the sleep quality.

  4. The Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F) change value

    Time frame: 6 weeks

    The FACIT-F total score ranges from 0 to52, and the higher the score, the more fatigue.

Sponsors and collaborators

Lead sponsor

DongE E Jiao Coporation Limited

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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