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Randomized, double-blind, controlled clinical trial of Qizhi Tongluo Granules in the intervention of low-risk primary membranous nephropathy

Randomized, double-blind, controlled clinical trial of Qizhi Tongluo Granules in the intervention of low-risk primary membranous nephropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075033
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Membranous nephropathy

Interventions

Observation group:Qizhi Tongluo granules for oral administration
Control group:Qizhi Tongluo granule simulation agent for oral administration

Sponsors

Hebei Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)He was diagnosed with stage I-III PMN within 2 years. The pathology of renal puncture meets the following requirements: no less than 12 glomeruli should be examined by light microscopy, and all renal tissue specimens should be examined by light microscopy and immunofluorescence at least; (2)18-65 years old; (3)Anti-phospholipase A2 receptor antibody positive (indirect immunofluorescence IFA); (4)eGFR is normal, 24-hour urinary protein volume < 3.5g/24h, and/or blood albumin greater than 30g/L; (5)Take a stable dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-? receptor blocker (ARB) for at least 8 weeks at the maximum or tolerated dose recommended by the guidelines (dose change <25%); (6)It meets the classification standard of Qi deficiency (including lung qi deficiency, spleen kidney qi deficiency, lung and kidney deficiency) and blood stasis syndrome (including blood stasis blocking collaterality syndrome, blood stasis and water interjunction syndrome).

Exclusion criteria

Exclusion criteria: (1)Patients with various secondary MN caused by autoimmune diseases, tumors, hepatitis B, infections and drugs; (2)HIV/AIDS, hepatitis B or C virus positive; (3)Abnormal liver function, leukopenia or immune deficiency; (4)Patients with severe digestive tract diseases, infections, diabetes, malignant tumors and serious cardiovascular and cerebrovascular diseases; (5)There are systemic bleeding tendency diseases, such as hemophilia, idiopathic thrombocytopenic purpura, etc; (6)There are severe, disabling, or life threatening complications associated with nephrotic syndrome; (7)Patients who are pregnant or planning to breastfeed; (8)Patients who have received cytotoxic drugs, immunosuppressants and other drugs in the past 1 month; (9)Double kidney color ultrasound indicates renal artery stenosis; (10)Allergic to animal protein; (11)Kidney transplant patient; (12)Those who the researcher considers unable to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
Complete and partial remission of MN at 24 weeks of treatment;

Secondary

MeasureTime frame
Changes in eGFR compared to baseline at 4, 12, and 24 weeks of treatment;Median time of complete and partial remission;Health related quality of life evaluated using the EQ-5D questionnaire;Traditional Chinese Medicine Syndrome Points;

Countries

China

Contacts

Public ContactJinchuan Tan

Hebei Provincial Hospital of Traditional Chinese Medicine

1955981973@qq.com+86 138 3118 7910

Outcome results

None listed

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