Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia
BXYMIDA
Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 8, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedFebruary 13, 2018
February 1, 2018
1.6 years
July 8, 2017
February 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Blood Count
Anemia Related Assessment
5 minutes
Secondary Outcomes (7)
The Short Form-36 Health Survey (Sf-36)
10 minutes
Hepatic Function
5 minutes
Renal Function
5 minutes
Blood Glucose
5 minutes
Electrolyte Semiconductor Junction
5 minutes
- +2 more secondary outcomes
Other Outcomes (1)
Metabonomics Measurement
1hour
Study Arms (3)
Buxue Yimu Pills
EXPERIMENTALBuxue Yimu Pill 12g pill by mouth, twice daily
Buxue Yimu Pills &Ferrous Sulfate
EXPERIMENTALBuxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Ferrous Sulfate
ACTIVE COMPARATORFerrous Sulfate 0.3g tablet by mouth, three times daily
Interventions
Buxue Yimu Pills 12g pill by mouth, twice daily.
Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Eligibility Criteria
You may qualify if:
- Subject is a female between the age of 18 and 50.
- 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.
You may not qualify if:
- Subject underwent chronic digestive tract inflammation，uncontrolled digestive or urinary system bleeding.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 10000, China
Related Publications (3)
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.
PMID: 28029503RESULTSeid 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.
PMID: 28487769RESULTWang 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.
PMID: 34241801DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aijun AJ Sun, MD
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 8, 2017
First Posted
July 28, 2017
Study Start
June 1, 2017
Primary Completion
December 31, 2018
Study Completion
February 28, 2019
Last Updated
February 13, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- Within 2 months after the trial complete
- Access Criteria
- 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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