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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
360
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:20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.
Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityBeijing Maternal and Child Health Care Hospital
Beijing, China
Hemoglobin(Hb) change value
Hb changes after 6 weeks of continuous medication
Time frame: 6 weeks
The proportion of hemoglobin returned to normal
Hb returned to normal proportions after 6 weeks of continuous medication
Time frame: 6 weeks
The proportion of hemoglobin rising > 20g/L
The proportion of Hb increased \>20g/L after 6 weeks of continuous administration
Time frame: 6 weeks
The proportion of hemoglobin rising > 10g/L
The proportion of Hb increased \>10g/L after 6 weeks of continuous administration
Time frame: 6 weeks
serum iron change value
serum iron changes after 6 weeks of continuous medication
Time frame: 6 weeks
serum ferritin change value
serum ferritin changes after 6 weeks of continuous medication
Time frame: 6 weeks
Red Blood Cell(RBC) change value
RBC changes after 6 weeks of continuous medication
Time frame: 6 weeks
Hematocrit(HCT )change value
HCT changes after 6 weeks of continuous medication
Time frame: 6 weeks
Traditional Chinese Medicine symptom score(a self-made scale for Qi-blood Deficiency Syndrome) change value
The TCM Qi and blood deficiency scale total score ranges from 0 to 54, and the higher the score, the more serious it is.
Time frame: 6 weeks
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