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Clinical observation of Yishen Jiangzhuo therapy in the treatment of non-dialysis renal anemia patients with stage 3–4 chronic kidney disease

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16119881
Enrollment
100
Registered
2026-07-15
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of renal anemia in non-dialysis adult patients with stage 3–4 chronic kidney disease Urological and Genital Diseases

Interventions

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 rand
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 cour
angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers and statins will be prescribed appropriately, and all nephrotoxic drugs will be prohibited Treatment Group Intervention (Ide

Sponsors

Hebei Provincial Administration of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 69 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change in hemoglobin (Hb) level measured using fasting venous blood hemoglobin concentration via Sysmex XN-9000 automatic hematology analyzer, unit: g/L at baseline (week 0), week 8;Change in reticulocyte hemoglobin content (CHr) measured using reticulocyte mean fluorescence intensity by Sysmex XN flow cytometry and convert to CHr value, unit: pg at baseline (week 0), week8;Change in soluble transferrin receptor (sTfR) measured using immunoturbidimetry assay on Roche Cobas c702 analyzer with matched reagents, unit: mg/L at baseline (week 0), week 8

Countries

China

Contacts

Public ContactGang Wang
wanggang_920929@163.com+86 15831164937

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026