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A multicenter randomized double-blind placebo-controlled parallel study on the effectiveness and safety of Xueniaan Capsule in the treatment of glomerular hematuria

A multicenter randomized double-blind placebo-controlled parallel study on the effectiveness and safety of Xueniaan Capsule in the treatment of glomerular hematuria

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000879
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Glomerular hematuria

Interventions

experimental group:Routine treatment+Xueniaoan capsule
Control group:Conventional treatment+Xueniaoan capsule simulant

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old, regardless of sex; (2)eGFR=30 ml/(min×1.73m2) (using CKD-EPI formula); (3) Glomerular hematuria (hereinafter referred to as renal hematuria) meets any of the following: Clinical diagnosis of glomerular hematuria: Take clean middle urine (women avoid menstrual period and 3 days before and after it, men avoid semen and prostatic fluid pollution), and send it for inspection within 30 minutes after leaving urine, and send it for urine routine and urine phase contrast microscope examination at the same time with a single sampling. At the same time, it should be satisfied: 1) the red blood cell count of urine sediment microscopy is > 3 /HP, or the red blood cell count is > 25/UL; 2) Abnormal red blood cells in urine phase contrast microscope =50%, or the information of urine red blood cells indicates heterogeneity; Pathological diagnosis confirmed primary glomerulonephritis (including IgA nephropathy, non-IgA mesangial proliferative glomerulonephritis, etc.) or secondary glomerulonephritis (including lupus nephritis, allergic purpura nephritis, etc.). (4) Those who voluntarily participate in the experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Yang deficiency syndrome (mainly manifested by cold limbs); (2) Patients who have used or are using aspirin heparin or low molecular weight heparin warfarin dipyridamole and other drugs in the past week; (3) Patients who have used are using or may start to use glucocorticoid immunosuppressant (including tripterygium wilfordii alkylating agent calcineurin inhibitor mycophenolate mofetil etc.) and targeted biological agents (anti-CD20 monoclonal antibody Tatasip etc.) within 3 months before enrollment; (4) Patients with new primary or secondary tumors within 6 months before enrollment and patients receiving anti-tumor treatment; (5) Patients with severe abnormal liver function (bilirubin or transaminase more than double the normal upper limit) or severe coagulation dysfunction or severe thrombocytopenia (platelet < 50×109/L); (6) Malformation of urinary system active infection of urogenital system (including urinary tuberculosis etc.) tumor of urinary system etc. (7) Female subjects of childbearing age who have positive pregnancy test are pregnant or breast-feeding or have pregnancy and breast-feeding plans during the study period and have not taken effective contraceptive measures; (8) people with allergic constitution or allergic to experimental drugs; (9) Participated in other clinical studies within one month before the start of the study; (10)Patients with low compliance which the researchers think are not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Hematuria improvement rate;

Secondary

MeasureTime frame
The improvement rate of hematuria after 2, 4, 8, 12, 16 and 20 weeks of treatment.;Tcm syndrome score;Proteinuria index (UACR);Renal function index;Proteinuria index (24h UTP);Serological index;Proportion of complete remission of hematuria;

Countries

China

Contacts

Public ContactDing Xiaoqiang

Zhongshan Hospital Affiliated to Fudan University

Ding.Xiaoqiang@zs-hospital.sh.cn13601968215

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026