Skip to content

Clinical Study on Dampness Dispelling, Blood Stasis Resolving, and Spleen Invigorating Method in the Treatment of IgA Nephropathy (Stage CKD1-2)

Clinical Study on Dampness Dispelling, Blood Stasis Resolving, and Spleen Invigorating Method in the Treatment of IgA Nephropathy (Stage CKD1-2)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082620
Enrollment
Unknown
Registered
2024-04-02
Start date
2024-04-02
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

IgA Nephropathy

Interventions

Treatment group:Basic treatment + potassium irbesartan 50mg qd + Huangqi Xiaobai granules
Control group:Basic treatment + potassium irbesartan 50mg qd + placebo

Sponsors

Yueyang Integrated Traditional Chinese and Western Medicine Hospital, Affiliated with Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Aged =18 and =75 years, gender not limited; 2.Pathologically diagnosed with IgA Nephropathy; 3.Kidney function: stages 1-2; 4.Traditional Chinese medicine syndrome differentiation meets the criteria of dampness, stasis, lung-spleen qi deficiency; 5.24-hour urine protein quantification =0.3g and =2.5g; 6.Participants who understand, agree to participate in the study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Received immunosuppressive or cytotoxic therapy for >4 weeks within the past 3 months; 2.Received a dosage of glucocorticoids (prednisone or prednisolone) >20mg/d for >4 weeks within the past 3 months; 3.Acute or rapidly progressive nephritis, acute progressive IgA Nephropathy; 4.Active hepatitis B with persistent abnormal liver function transaminases; 5.Patients with malignant tumors or a history of malignant tumors, HIV infection, psychiatric history, acute central nervous system disorders, severe gastrointestinal diseases, or contraindications to glucocorticoid use; 6.Abnormal glucose metabolism, fasting blood glucose >6.2mmol/L; 7.Pregnant or lactating women; 8.Participants currently enrolled in other clinical trials; 9.Complications that are life-threatening, such as severe infection or severe organ dysfunction; 10.Secondary factors causing IgA diseases, such as allergic purpura nephritis, chronic alcoholic liver disease, ankylosing spondylitis, psoriasis, lupus nephritis, etc.; severe primary diseases affecting the heart, brain, liver, and hematopoietic system; psychiatric patients; participants allergic to the investigational drug or intolerant to known adverse reactions.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;Traditional Chinese medicine syndrome;

Secondary

MeasureTime frame
Glomerular filtration rate;Serum creatinine;Complete Blood Count;Liver function;Pplasma potassium;Electrocardiogram;

Countries

China

Contacts

Public ContactQian Jingfeng

Yueyang Integrated Traditional Chinese and Western Medicine Hospital, Affiliated with Shanghai University of Traditional Chinese Medicine

qjf9301@163.com+86 181 0194 2258

Outcome results

None listed

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