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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Hemoglobin（Hb） change value
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
compound E Jiao Jiang(cEJJ)
20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.
干预措施: compound E Jiao Jiang(cEJJ) (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.
干预措施: compound E Jiao Jiang(cEJJ) placebo (Drug)
结局指标
主要结局
Hemoglobin（Hb） change value
时间窗: 6 weeks
Hb changes after 6 weeks of continuous medication
次要结局
- serum iron change value(6 weeks)
- Red Blood Cell（RBC） change value(6 weeks)
- The proportion of hemoglobin returned to normal(6 weeks)
- The proportion of hemoglobin rising > 20g/L(6 weeks)
- serum ferritin change value(6 weeks)
- The proportion of hemoglobin rising > 10g/L(6 weeks)
- Hematocrit（HCT ）change value(6 weeks)
- Traditional Chinese Medicine symptom score（a self-made scale for Qi-blood Deficiency Syndrome） change value(6 weeks)