A multicenter, prospective, randomized, controlled study on the efficacy and safety of Yishen Huashi Granules in the treatment of chronic kidney disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026000123

Enrollment

Unknown

Registered

2026-01-22

Start date

2025-11-04

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Chronic Kidney Disease (Stages 1-3)

Interventions

Experimental Group:Conventional treatment plus Yishen Huashi Granules

Control Group:Conventional treatment plus Yishen Huashi Granules placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects who meet all the following criteria will be included:(1) Aged 18-80 years, regardless of gender;(2) Meeting the western medical diagnostic criteria for Chronic Kidney Disease (CKD) at Stages 1-3, defined as an estimated Glomerular Filtration Rate (eGFR) = 30 ml/(min×1.73m^2) (calculated using the CKD-EPI formula);(3) 24-hour urinary protein (24h UTP) > 0.3 g and < 1 g;(4) Effectively controlled hypertension, severe infections, water-electrolyte and acid-base imbalances, and other comorbidities;(5) Having signed the Informed Consent Form (ICF).

Exclusion criteria

Exclusion criteria: Exclusion Criteria (Subjects meeting any of the following criteria will be excluded):(1) Patients who have used, are currently using, or are assessed to potentially start using glucocorticoids, immunosuppressants (including Tripterygium wilfordii preparations, alkylating agents, calcineurin inhibitors, mycophenolate mofetil, etc.), or targeted biological agents (anti-CD20 monoclonal antibodies, telitacicept, etc.) within 3 months prior to enrollment;(2) Patients with severe primary diseases of the heart, brain, liver, hematopoietic system, or other organs;(3) Patients with complicated severe intestinal diseases;(4) Post-renal transplantation patients; pregnant or lactating women;(5) Patients with known allergies to the study drugs;(6) Patients currently participating in other drug clinical trials or who have participated in other clinical trials within 3 months.

Design outcomes

Primary

Measure	Time frame
Microalbuminuria;	—

Secondary

Measure	Time frame
Serum Creatinine/Estimated Glomerular Filtration Rate;Traditional Chinese Medicine (TCM) Syndrome Score;Routine Urinalysis;Inflammatory Factor Levels (hs-CRP, IL-6);Hemoglobin;	—

Countries

China

Contacts

Public ContactXUxialian

Zhongshan Hospital Affiliated to Fudan University

xu.xialian@zs-hospital.sh.cn13564142468

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026