Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia (BXYMIDA)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Iron-Deficiency Anemia

Treatments: Drug: Buxue Yimu Pills; Drug: Ferrous Sulfate; Drug: Buxue Yimu Pills &Ferrous Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03232554

IDA201706

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Buxue Yimu Pills

Experimental group

Description:

Buxue Yimu Pill 12g pill by mouth, twice daily

Treatment:

Drug: Buxue Yimu Pills

Buxue Yimu Pills &Ferrous Sulfate

Experimental group

Description:

Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily

Treatment:

Drug: Buxue Yimu Pills &Ferrous Sulfate

Ferrous Sulfate

Active Comparator group

Description:

Ferrous Sulfate 0.3g tablet by mouth, three times daily

Treatment:

Drug: Ferrous Sulfate