跳至主要内容
临床试验/ISRCTN16119881
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

发起方
Hebei Provincial Administration of Traditional Chinese Medicine

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