Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Complete Blood Count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is a female between the age of 18 and
- •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.
排除标准
- •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.
研究组 & 干预措施
Ferrous Sulfate
Ferrous Sulfate 0.3g tablet by mouth, three times daily
干预措施: Ferrous Sulfate (Drug)
Buxue Yimu Pills
Buxue Yimu Pill 12g pill by mouth, twice daily
干预措施: Buxue Yimu Pills (Drug)
Buxue Yimu Pills &Ferrous Sulfate
Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
干预措施: Buxue Yimu Pills &Ferrous Sulfate (Drug)
结局指标
主要结局
Complete Blood Count
时间窗: 5 minutes
Anemia Related Assessment
次要结局
- The Short Form-36 Health Survey (Sf-36)(10 minutes)
- Hepatic Function(5 minutes)
- Iron Metabolism index(5 minutes)
- Renal Function(5 minutes)
- Blood Glucose(5 minutes)
- Electrolyte Semiconductor Junction(5 minutes)
- Electrocardiogram(ECG)(5 minutes)
研究者
Aijun Sun
Professor
Peking Union Medical College Hospital