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The prevalence of postpartum anemia is a great threat for maternal and infant health without timely and effective treatment. Oral iron therapy has been used for centuries as a treatment of anemia, however, it is noteworthy that treatment with oral iron might have a limited, and even a harmful role in some clinical scenarios. Ejiao compound is composed with donkey-hide glue, Ginseng, Codonopsis pilosula, prepared rhizome of rehmannia, and crab apple, which has been widely used in the treatment of various types of anemia in China for decades and might be a potentially effective therapy for postpartum anemia. Recently, studies involving animal subjects have helped shed light on its mechanism of action.
In this study, the investigators aimed to conduct a randomized controlled trial to assess the efficacy and safety of Ejiao compound comparing with oral iron in the treatment of mild postpartum anemia with or without iron deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ejiao compound | Experimental | The participants in experimental group receive Ejiao compound (20ml, twice daily) orally for 4 weeks. |
|
| Niferex | Active Comparator | The participants in control group receive Polysaccharide Iron Complex(Niferex)(150mg per tablet, once daily) orally after breakfast over 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ejiao compound | Drug | 20ml,twice daily, orally after breakfast Duration:4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin(Hb) | before and after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ferritin | before and after treatment | |
| Life quality assessment: a Health Assessment Questionnaire(The Short Form-36 Health Survey, SF-36) | before and after treatment | |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions or events: renal function | serum creatinine and urea nitrogen | before and after treatment |
| Adverse reactions or events: liver function | aspartate aminotransferase(AST), alanine aminotransferase (ALT) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanfang Li, PhD | Contact | +86 13928777126 | gzyanfangli@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| yanfang Li, PhD | the First Affiliated Hospital, Guangzhou University of Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510405 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15495089 | Background | Dodd J, Dare MR, Middleton P. Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004222. doi: 10.1002/14651858.CD004222.pub2. | |
| 17004982 | Background | Bhandal N, Russell R. Intravenous versus oral iron therapy for postpartum anaemia. BJOG. 2006 Nov;113(11):1248-52. doi: 10.1111/j.1471-0528.2006.01062.x. Epub 2006 Sep 27. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 15, 2017 | |
| Reset | Jul 24, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 15, 2017 | Jul 24, 2018 |
| ID | Term |
|---|---|
| C078972 | Niferex |
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| Niferex | Drug | one tablet,once daily, orally after breakfast Duration:4 weeks |
|
|
| Traditional Chinese Medicine symptom score:a self-made scale for Qi-blood Deficiency Syndrome |
| before and after treatment |
| before and after treatment |
| 22548729 | Background | Ramakers C, van der Woude DA, Verzijl JM, Pijnenborg JM, van Wijk EM. An added value for the hemoglobin content in reticulocytes (CHr) and the mean corpuscular volume (MCV) in the diagnosis of iron deficiency in postpartum anemic women. Int J Lab Hematol. 2012 Oct;34(5):510-6. doi: 10.1111/j.1751-553X.2012.01423.x. Epub 2012 May 1. |
| 20577752 | Background | Breymann C, Honegger C, Holzgreve W, Surbek D. Diagnosis and treatment of iron-deficiency anaemia during pregnancy and postpartum. Arch Gynecol Obstet. 2010 Nov;282(5):577-80. doi: 10.1007/s00404-010-1532-z. Epub 2010 Jun 25. |
| 21710167 | Background | Milman N. Postpartum anemia I: definition, prevalence, causes, and consequences. Ann Hematol. 2011 Nov;90(11):1247-53. doi: 10.1007/s00277-011-1279-z. Epub 2011 Jun 28. |
| 22160256 | Background | Milman N. Postpartum anemia II: prevention and treatment. Ann Hematol. 2012 Feb;91(2):143-54. doi: 10.1007/s00277-011-1381-2. Epub 2011 Dec 9. |
| 20303210 | Background | Bergmann RL, Richter R, Bergmann KE, Dudenhausen JW. Prevalence and risk factors for early postpartum anemia. Eur J Obstet Gynecol Reprod Biol. 2010 Jun;150(2):126-31. doi: 10.1016/j.ejogrb.2010.02.030. Epub 2010 Mar 29. |