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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postpartum Anemia

Intervention / Treatment
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* Drug: compound E Jiao Jiang(cEJJ)
* Drug: compound E Jiao Jiang(cEJJ) placebo


Participation Criteria
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Eligibility Criteria
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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); People with a history of alcoholism, drug abuse, or drug abuse; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: compound E Jiao Jiang(cEJJ)<br>20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. | Drug: compound E Jiao Jiang(cEJJ)<br>* compound E Jiao Jiang(cEJJ)：20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner.<br>* 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.）;|
| Placebo Comparator: compound E Jiao Jiang(cEJJ) placebo<br>20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. | Drug: compound E Jiao Jiang(cEJJ) placebo<br>* 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. ferrous succinate tablet：1 tablet at a time, 2 times a day, should be taken in the morning, after dinner or during meals.<br>* 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.）;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin（Hb） change value | Hb changes after 6 weeks of continuous medication | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of hemoglobin returned to normal | Hb returned to normal proportions after 6 weeks of continuous medication | 6 weeks | 
| The proportion of hemoglobin rising > 20g/L | The proportion of Hb increased >20g/L after 6 weeks of continuous administration | 6 weeks | 
| The proportion of hemoglobin rising > 10g/L | The proportion of Hb increased >10g/L after 6 weeks of continuous administration | 6 weeks | 
| serum iron change value | serum iron changes after 6 weeks of continuous medication | 6 weeks | 
| serum ferritin change value | serum ferritin changes after 6 weeks of continuous medication | 6 weeks | 
| Red Blood Cell（RBC） change value | RBC changes after 6 weeks of continuous medication | 6 weeks | 
| Hematocrit（HCT ）change value | HCT changes after 6 weeks of continuous medication | 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. | 6 weeks |