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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| compound E Jiao Jiang(cEJJ) | Experimental | 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 | Placebo Comparator | 20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compound E Jiao Jiang(cEJJ) | Drug | compound E Jiao Jiang(cEJJ):20ml (1 bottle) at a time, 3 times a day, should be taken orally before morning, lunch and dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin(Hb) change value | Hb changes after 6 weeks of continuous medication | 6 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression(EPDS) change value | The EPDS total score ranges from 0 to 30, and the higher the score, the severe the depression. | 6 weeks |
| Self-rating Anxiety Scale(SAS)change value | The SAS total score ranges from 0 to 80, and the higher the score, the greater the anxiety. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityBeijing Maternal and Child Health Care Hospital | Beijing | China |
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| compound E Jiao Jiang(cEJJ) placebo | 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. |
|
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| 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 |
| 6 weeks |
| Pittsburgh sleep quality index(PSQI) change value | The PSQI total score ranges from 0 to 21, and the higher the score, the worse the sleep quality. | 6 weeks |
| The Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F) change value | The FACIT-F total score ranges from 0 to52, and the higher the score, the more fatigue. | 6 weeks |