Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia

Last updated: February 10, 2018
Sponsor: Peking Union Medical College Hospital
Overall Status: Trial Status Unknown

Phase

2

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT03232554
IDA201706
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 110g/L.

  • Subject has definite gynecological etiological factors of iron deficiency

  • Subject provides written informed consent.

Exclusion

Exclusion Criteria:

  • Subject underwent chronic digestive tract inflammation,uncontrolled digestive orurinary system bleeding.

  • Subject has other complications in addition to gynecological diseases leading to irondeficiency,such as hemorrhagic diseases of hematologic system,parasitic diseases likeancylostomiasis,chronic intravascular hemolysis,mechanical hemolysis like prostheticvalve,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 supplementsor 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 priorto randomization.

Study Design

Total Participants: 180
Study Start date:
June 01, 2017
Estimated Completion Date:
February 28, 2019

Study 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.

Connect with a study center

  • Lei Li

    Beijing, Beijing 10000
    China

    Active - Recruiting

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