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
Treatment of renal anemia in non-dialysis adult patients with stage 3–4 chronic kidney disease
Group Allocation Method All eligible participants will be assigned at a 1:1 ratio to either the treatment group or the control group via block randomisation with a block size of 4 combined with a random number table. An independent statistician will generate the random sequence and seal it in opaque envelopes; researchers will open envelopes sequentially according to participant enrolment order to complete group allocation. Control Group Intervention (Usual Western Medicine Care, 8-week full treatment course) Every participant in the control group will receive standard conventional Western medical therapy throughout the trial: 1. Recombinant human erythropoietin injection (Yibi'ao, Shenyang Sansheng Pharmaceutical): 3000 IU administered subcutaneously three times per week (Monday, Wednesday, Friday). Clinicians will adjust dosage dynamically: reduce to twice weekly if haemoglobin exceeds 120 g/L, suspend injection if haemoglobin rises above 130 g/L, and resume the original dose once haemoglobin drops below 120 g/L 2. Ferrous succinate tablets (Suliferr, Jinling Pharmaceutical): 0.2 g taken orally three times daily after meals to relieve gastrointestinal irritation 3. Unified basic kidney protective management: medical staff will control participants’ blood pressure below 130/80 mmHg, glycated haemoglobin under 7.0%, and low-density lipoprotein cholesterol less than 2.6 mmol/L; angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers and statins will be prescribed appropriately, and all nephrotoxic drugs will be prohibited Treatment Group Intervention (Identical Western Medicine plus Yishen Jiangzhuo Herbal Decoction, 8-week full treatment course) Each participant in the treatment group will receive the exact same conventional Western medical therapy as the control group, with the additional oral administration of Yishen Jiangzhuo herbal decoction: 1. Herbal formula composition: Astragali Radix 30 g, Codonopsis Radix 15 g, Angelicae Sinensis Radix
1. Aged 21 to 69 years old, no gender limitation 2. 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 3. Meet the diagnostic criteria for renal anemia: hemoglobin level less than 120 g/L for males and less than 110 g/L for females 4. No recombinant human erythropoietin or intravenous iron agents administered within four weeks before enrollment 5. Serum ferritin higher than 100 ng/mL and transferrin saturation above 20% to rule out absolute iron deficiency 6. Voluntarily participate and sign written informed consent
1. Anemia caused by gastrointestinal hemorrhage, hemolysis and hematological diseases including aplastic anemia, myelodysplastic syndrome and thalassemia 2. 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 3. Individuals with allergies to ingredients of investigational drugs such as ferrous succinate, erythropoietin and components of traditional Chinese herbal prescriptions 4. Pregnant or lactating women 5. Participants enrolled in other ongoing clinical trials 6. Subjects with poor treatment compliance or those deemed ineligible for enrolment by researchers for other reasons