ISRCTN16119881进行中(未招募)不适用
A prospective randomized controlled trial comparing conventional western medical therapy alone versus conventional western medical therapy combined with kidney-tonifying turbidity-reducing herbal therapy for improving anemia status, iron metabolism, renal function and inflammatory levels, reducing weekly erythropoietin dosage and evaluating safety among non-dialysis adults with stage three to four chronic kidney disease and renal anemia
Hebei Provincial Administration of Traditional Chinese Medicine0 个研究点目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
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
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 69 Years(—)
- 性别
- All
入选标准
- •Aged 21 to 69 years old, no gender limitation
- •Diagnosed with stage 3–4 chronic kidney disease with estimated glomerular filtration rate of 15–59 mL/min/1.73 m² and not receiving dialysis
- •Meet the diagnostic criteria for renal anemia: hemoglobin level less than 120 g/L for males and less than 110 g/L for females
- •No recombinant human erythropoietin or intravenous iron agents administered within four weeks before enrollment
- •Serum ferritin higher than 100 ng/mL and transferrin saturation above 20% to rule out absolute iron deficiency
- •Voluntarily participate and sign written informed consent
排除标准
- •Anemia caused by gastrointestinal hemorrhage, hemolysis and hematological diseases including aplastic anemia, myelodysplastic syndrome and thalassemia
- •Patients complicated with severe infection, hepatic insufficiency with alanine transaminase/aspartate transaminase levels exceeding three times the upper limit of normal values, malignant tumors or active autoimmune diseases
- •Individuals with allergies to ingredients of investigational drugs such as ferrous succinate, erythropoietin and components of traditional Chinese herbal prescriptions
- •Pregnant or lactating women
- •Participants enrolled in other ongoing clinical trials
- •Subjects with poor treatment compliance or those deemed ineligible for enrolment by researchers for other reasons
研究者
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