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This study evaluates Buxue Yimu Pills,Ferrous Sulfate and the addition of Buxue Yimu Pills to Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate,and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
Buxue Yimu Pills, Ferrous Sulfate each Improve anemia, but they do so by different machanisms. We generally treat patients with uncomplicated Iron Deficiency Anemia with oral iron due to the ease of administration,and Ferrous Sulfate is one of the most commonly used drugs.
Buxue Yimu Pills consists of multiple chinses herbs including Angelica Sinensis,Astragalus,Donkey-Hide Gelatin,Herba Leonuri,Citrus etc., which gains widespread application in the treatment after women's abortion or operations of uterine cavity. Based on the characteristics above, we try to explore its clinical application value in Gynecological Iron-Deficiency Anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buxue Yimu Pills | Experimental | Buxue Yimu Pill 12g pill by mouth, twice daily |
|
| Buxue Yimu Pills &Ferrous Sulfate | Experimental | Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily |
|
| Ferrous Sulfate | Active Comparator | Ferrous Sulfate 0.3g tablet by mouth, three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buxue Yimu Pills | Drug | Buxue Yimu Pills 12g pill by mouth, twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Blood Count | Anemia Related Assessment | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The Short Form-36 Health Survey (Sf-36) | Information about health | 10 minutes |
| Hepatic Function | Safety Monitoring | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Metabonomics Measurement | Extensive and profound Information | 1hour |
Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei L Li, MD | Contact | 139-1198-8831 | +86 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Aijun AJ Sun, MD | Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 10000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28029503 | Result | Percy L, Mansour D, Fraser I. Iron deficiency and iron deficiency anaemia in women. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:55-67. doi: 10.1016/j.bpobgyn.2016.09.007. Epub 2016 Oct 1. | |
| 28487769 | Result | Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13. |
| Label | URL |
|---|---|
| Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. | View source |
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Network platform, and the website will be attached later.
Within 2 months after the trial complete
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2017 | Jul 9, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 | Jul 9, 2017 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate,and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
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| Buxue Yimu Pills &Ferrous Sulfate | Drug | Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily |
|
|
| Ferrous Sulfate | Drug | Ferrous Sulfate 0.3g tablet by mouth, three times daily |
|
|
| Renal Function | Safety Monitoring | 5 minutes |
| Blood Glucose | Safety Monitoring | 5 minutes |
| Electrolyte Semiconductor Junction | Safety Monitoring | 5 minutes |
| Electrocardiogram(ECG) | Safety Monitoring | 5 minutes |
| Iron Metabolism index | Anemia Related Assessment | 5 minutes |
| 34241801 | Derived | Wang YF, Deng Y, Zhang SY, Liu D, Luo B, Wang X, Deng M, Ma RL, Sun AJ. Efficacy and Mechanism of Buxue Yimu Pills on Gynecological Anemia: A Combination of Clinical and Network Pharmacology Study. Chin J Integr Med. 2022 Dec;28(12):1072-1080. doi: 10.1007/s11655-021-3296-7. Epub 2021 Jul 9. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |