Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia
NCT ID: NCT03232554
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2017-06-01
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Buxue Yimu Pills
Buxue Yimu Pill 12g pill by mouth, twice daily
Buxue Yimu Pills
Buxue Yimu Pills 12g pill by mouth, twice daily.
Buxue Yimu Pills &Ferrous Sulfate
Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Buxue Yimu Pills &Ferrous Sulfate
Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Ferrous Sulfate
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Ferrous Sulfate
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Interventions
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Buxue Yimu Pills
Buxue Yimu Pills 12g pill by mouth, twice daily.
Buxue Yimu Pills &Ferrous Sulfate
Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Ferrous Sulfate
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject suffers from mild to moderate anemia with a hemoglobin between 80g/L and 110 g/L.
* Subject has definite gynecological etiological factors of iron deficiency
* Subject provides written informed consent.
Exclusion Criteria
* Subject has other complications in addition to gynecological diseases leading to iron deficiency，such as hemorrhagic diseases of hematologic system，parasitic diseases like ancylostomiasis，chronic intravascular hemolysis，mechanical hemolysis like prosthetic valve，renal dysfunction and hemodialysis.
* Subject is pregnant or lactating.
* Subject has a severe systemic disease, such as cardiovascular system
* Subject has a history of malignancy or radiotherapy.
* Subject has undergone any Iron deficiency anemia treatment including Iron supplements or blood transfusion within 1month prior to randomization.
* Subject has mental disorder incapable of elementary cooperations.
* Subject has participated in other clinical researches of medicine within 1month prior to randomization.
18 Years
50 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Aijun Sun
Professor
Principal Investigators
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Aijun AJ Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Locations
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Lei Li
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.
Other Identifiers
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IDA201706
Identifier Type: -
Identifier Source: org_study_id
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