Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityBeijing Maternal and Child Health Care Hospital
Beijing, China
NCT Number: NCT06175117
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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Notify Me18 year–45 year
Female
Interventional
Phase 4
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: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.)
Time frame: 6 weeks
Hb changes after 6 weeks of continuous medication
Time frame: 6 weeks
Hb returned to normal proportions after 6 weeks of continuous medication
Time frame: 6 weeks
The proportion of Hb increased >20g/L after 6 weeks of continuous administration
Time frame: 6 weeks
The proportion of Hb increased >10g/L after 6 weeks of continuous administration
Time frame: 6 weeks
serum iron changes after 6 weeks of continuous medication
Time frame: 6 weeks
serum ferritin changes after 6 weeks of continuous medication
Time frame: 6 weeks
RBC changes after 6 weeks of continuous medication
Time frame: 6 weeks
HCT changes after 6 weeks of continuous medication
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.
Time frame: 6 weeks
The EPDS total score ranges from 0 to 30, and the higher the score, the severe the depression.
Time frame: 6 weeks
The SAS total score ranges from 0 to 80, and the higher the score, the greater the anxiety.
Time frame: 6 weeks
The PSQI total score ranges from 0 to 21, and the higher the score, the worse the sleep quality.
Time frame: 6 weeks
The FACIT-F total score ranges from 0 to52, and the higher the score, the more fatigue.
DongE E Jiao Coporation Limited
Industry
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
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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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