Back to resultsBuxue Yimu Pills for Gynecological Iron-Deficiency Anemia (BXYMIDA)
Primary Purpose
Iron-Deficiency Anemia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Buxue Yimu Pills
Buxue Yimu Pills &Ferrous Sulfate
Ferrous Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Iron-Deficiency Anemia focused on measuring Iron-Deficiency Anemia, Buxue Yimu Pills, Ferrous Sulfate, clinical observations, adult women, Metabonomics
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Buxue Yimu Pills
Buxue Yimu Pills &Ferrous Sulfate
Ferrous Sulfate
Arm Description
Buxue Yimu Pill 12g pill by mouth, twice daily
Buxue Yimu Pill 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
Outcomes
Primary Outcome Measures
Complete Blood Count
Anemia Related Assessment
Secondary Outcome Measures
The Short Form-36 Health Survey (Sf-36)
Information about health
Hepatic Function
Safety Monitoring
Renal Function
Safety Monitoring
Blood Glucose
Safety Monitoring
Electrolyte Semiconductor Junction
Safety Monitoring
Electrocardiogram(ECG)
Safety Monitoring
Iron Metabolism index
Anemia Related Assessment
Full Information
NCT ID
NCT03232554
First Posted
July 8, 2017
Last Updated
February 10, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03232554
Brief Title
Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia
Acronym
BXYMIDA
Official Title
Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-Deficiency Anemia
Keywords
Iron-Deficiency Anemia, Buxue Yimu Pills, Ferrous Sulfate, clinical observations, adult women, Metabonomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buxue Yimu Pills
Arm Type
Experimental
Arm Description
Buxue Yimu Pill 12g pill by mouth, twice daily
Arm Title
Buxue Yimu Pills &Ferrous Sulfate
Arm Type
Experimental
Arm Description
Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Arm Title
Ferrous Sulfate
Arm Type
Active Comparator
Arm Description
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Intervention Type
Drug
Intervention Name(s)
Buxue Yimu Pills
Other Intervention Name(s)
Buxue Yimu pellets
Intervention Description
Buxue Yimu Pills 12g pill by mouth, twice daily.
Intervention Type
Drug
Intervention Name(s)
Buxue Yimu Pills &Ferrous Sulfate
Other Intervention Name(s)
Buxue Yimu pellets,Iron Sulfate
Intervention Description
Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Other Intervention Name(s)
Iron Sulfate
Intervention Description
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Primary Outcome Measure Information:
Title
Complete Blood Count
Description
Anemia Related Assessment
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
The Short Form-36 Health Survey (Sf-36)
Description
Information about health
Time Frame
10 minutes
Title
Hepatic Function
Description
Safety Monitoring
Time Frame
5 minutes
Title
Renal Function
Description
Safety Monitoring
Time Frame
5 minutes
Title
Blood Glucose
Description
Safety Monitoring
Time Frame
5 minutes
Title
Electrolyte Semiconductor Junction
Description
Safety Monitoring
Time Frame
5 minutes
Title
Electrocardiogram(ECG)
Description
Safety Monitoring
Time Frame
5 minutes
Title
Iron Metabolism index
Description
Anemia Related Assessment
Time Frame
5 minutes
Other Pre-specified Outcome Measures:
Title
Metabonomics Measurement
Description
Extensive and profound Information
Time Frame
1hour
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei L Li, MD
Phone
139-1198-8831
Ext
＋86
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aijun AJ Sun, MD
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei L Li, MD
Phone
13911988831
Ext
＋86
Email
lileigh@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Network platform, and the website will be attached later.
IPD Sharing Time Frame
Within 2 months after the trial complete
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
28029503
Citation
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.
Results Reference
result
PubMed Identifier
28487769
Citation
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.
Results Reference
result
PubMed Identifier
34241801
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406716/
Description
Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.
Learn more about this trial
Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia
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