Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Hemoglobin(Hb)
研究概览
简要总结
Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured before and after treatments.
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of minor or intermediate β- thalassemia;
- •patients with mild anemia (80 g/L≤ Hb<110 g/L) prior to study enrollment;
- •singleton pregnancy;
- •patients having not received blood transfusion or any forms of anti-anemia treatment in Western Medicine or Traditional Chinese Medicine in the last 12 weeks;
- •informed consent obtained.
排除标准
- •patients with severe thalassemia;
- •patients with severe anemia (Hb<80 g/L) prior to study enrollment;
- •twin or multiple pregnancies;
- •patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
- •allergic to two or more drugs;
- •patients with mental illness or poor compliance to medical treatment;
- •patients having received blood transfusion or any forms of anti-anemia treatment in Western medicine or Traditional Chinese Medicine in the last 12 weeks;
- •no informed consent obtained.
研究组 & 干预措施
Intervention group
Patients in the treatment group received daily 15 g oral Colla corii asini(Shandong Dong-E E-Jiao Co., Ltd) in powder form for 4 consecutive weeks. The dosage was adjusted to 10 g per day for 6 consecutive weeks if patients encounter any of the following side effects: swollen gums, dry or sore throat, ulcers in oral cavity.
干预措施: Colla corii asini (Drug)
结局指标
主要结局
Hemoglobin(Hb)
时间窗: Four weeks
the change of hemoglobin(g/L)
Adult hemoglobin(HbA)
时间窗: Four weeks
the change of adult hemoglobin(%)
Fetal hemoglobin(HbF)
时间窗: Four weeks
the change of fetal hemoglobin(%)
Minor adult hemoglobin(HbA2)
时间窗: Four weeks
the change of minor adult hemoglobin(%)
次要结局
- Serum iron(SI)(Four weeks)
- Serum ferritin(SF)(Four weeks)
- Adverse effect(Four weeks)
研究者
Yanfang Li
Dr.
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine