Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia

Iron-Deficiency Anemia Clinical Trial

— BXYMIDA  

Official title:

Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03232554
• Other study ID #: IDA201706
• Status: Recruiting
• Phase: Phase 2
• First received: July 8, 2017
• Last updated: February 10, 2018
• Start date: June 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei L Li, MD
• Phone: 139-1198-8831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 28, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron-Deficiency Anemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabonomics Measurement	Extensive and profound Information	1hour
Primary	Complete Blood Count	Anemia Related Assessment	5 minutes
Secondary	The Short Form-36 Health Survey (Sf-36)	Information about health	10 minutes
Secondary	Hepatic Function	Safety Monitoring	5 minutes
Secondary	Renal Function	Safety Monitoring	5 minutes
Secondary	Blood Glucose	Safety Monitoring	5 minutes
Secondary	Electrolyte Semiconductor Junction	Safety Monitoring	5 minutes
Secondary	Electrocardiogram(ECG)	Safety Monitoring	5 minutes
Secondary	Iron Metabolism index	Anemia Related Assessment	5 minutes

External Links

•   Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.
•   Iron deficiency and iron deficiency anaemia in women