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Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01845688
Enrollment
72
Registered
2013-05-03
Start date
2011-11-30
Completion date
2016-09-30
Last updated
2023-04-20

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

Conditions

Idiopathic Membranous Nephropathy

Keywords

Idiopathic Membranous Nephropathy, Traditional Chinese Medicine, Randomized Control Trial

Brief summary

The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.

Interventions

DRUGLosartan Tablets & QingReMoShen Granule
DRUGLosartan Tablets & Placebo Granule

Sponsors

wanglin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy; * 6.0g≥24 hour urinary protein≥1.0g; * serum albumin concentration≥26g/L; * Chronic Kidney Disease (CKD)≤3 stage (eGFR\>30ml/min/1.73m2 MDRD); * Willing to participate in the trial and signed an informed consent.

Exclusion criteria

* Secondary membranous nephropathy; * Patients with one of the following circumstances- malignant tumors or malignancy, HIV infection, a history of mental illness, any serious systemic infection, serious gastrointestinal diseases, circulating hepatitis B surface antigens positive or persistent abnormal serum transaminase, abnormal glucose metabolism or diabetes mellitus; * Pregnant and lactating women; * Undergoing other clinical trials.

Design outcomes

Primary

MeasureTime frame
24-hour urine proteinAt the 24thweek

Secondary

MeasureTime frame
serum albumin concentrationAt the 24thweek
eGFRAt the 24thweek
Alanine transaminaseAt the 24thweek

Other

MeasureTime frameDescription
T-cell classificationAt the 24thweekDetecting by flow cytometry method

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026