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Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured before and after treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients in the treatment group received daily 15 g oral Colla corii asini(Shandong Dong-E E-Jiao Co., Ltd) in powder form for 4 consecutive weeks. The dosage was adjusted to 10 g per day for 6 consecutive weeks if patients encounter any of the following side effects: swollen gums, dry or sore throat, ulcers in oral cavity. |
|
| Control group | No Intervention | Patients in control groups do not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colla corii asini | Drug | 15 g of Colla corii asini in powder form daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin(Hb) | the change of hemoglobin(g/L) | Four weeks |
| Adult hemoglobin(HbA) | the change of adult hemoglobin(%) | Four weeks |
| Fetal hemoglobin(HbF) | the change of fetal hemoglobin(%) | Four weeks |
| Minor adult hemoglobin(HbA2) | the change of minor adult hemoglobin(%) | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum iron(SI) | the change of serum iron (umol/L) | Four weeks |
| Serum ferritin(SF) | the change of serum ferritin (ng/mL) | Four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanfang Li, PhD | Contact | +86-20-36598857 | gzyanfangli@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510405 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24889414 | Background | Voskaridou E, Balassopoulou A, Boutou E, Komninaka V, Christoulas D, Dimopoulou M, Delaki EE, Loukopoulos D, Terpos E. Pregnancy in beta-thalassemia intermedia: 20-year experience of a Greek thalassemia center. Eur J Haematol. 2014 Dec;93(6):492-9. doi: 10.1111/ejh.12387. Epub 2014 Jun 26. | |
| 26142322 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2017 | |
| Reset | Jul 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2017 | Jul 12, 2018 |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000612945 | colla corii asini |
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| Adverse effect | total white blood count(×109/L) | Four weeks |
| Adverse effect | platelet count(×109/L) | Four weeks |
| Adverse effect | percentage of neutrophil(%) | Four weeks |
| Adverse effect | serum alanine aminotransferase(U/L) | Four weeks |
| Adverse effect | serum aspartate aminotransferase(U/L) | Four weeks |
| Adverse effect | urea nitrogen (mmol/L) | Four weeks |
| Adverse effect | serum creatinine(umol/L) | Four weeks |
| Costa D, Capuano M, Sommese L, Napoli C. Impact of epigenetic mechanisms on therapeutic approaches of hemoglobinopathies. Blood Cells Mol Dis. 2015 Aug;55(2):95-100. doi: 10.1016/j.bcmd.2015.05.004. Epub 2015 May 12. |
| 22512001 | Background | Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |