Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ） (NCT06175117) | Clinical Trial Compass
CompletedPhase 4
Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）
China360 participantsStarted 2023-01-07
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);