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Effects of wubi shanyao pill for treating IgA nephropathy with moderate/high-risk of kidney failure: a randomized controlled trial

Effects of wubi shanyao pill for treating IgA nephropathy with moderate/high-risk of kidney failure: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052079
Enrollment
Unknown
Registered
2021-10-16
Start date
2021-10-30
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

IgA nephropathy

Interventions

Experimental group:Western medicine basic treatment and Wubi Shanyao Pill
Control group:Western medicine basic treatment and placebo

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, <= 75 years; 2. Pathologically clearly diagnosed as IgA nephropathy; 3. Blood pressure is controlled at < 140/90 mmHg, and blood sugar is controlled at fasting blood glucose < 8.0 mmol/L or HbA1c < 8.0%; 4. Control of blood lipids and blood uric acid up to standard; 5. 24h urine protein quantitative is greater than 0.5 g, less than 3.5 g; 6. Renal failure risk prediction grade (eight-factor method) is medium to high risk; 7. Volunteer to participate in this trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are contraindicated in the use of Wubi Shanyao Pills, including those with a history of diabetes, impaired gastrointestinal function or gastrointestinal diseases; 2. Those who have combined infections, severe cardiovascular and cerebrovascular diseases, liver insufficiency, hematopoietic diseases or malignant tumors; 3. Patients with secondary IgA nephropathy; 4. Pregnant, lactating women and women of childbearing age who are going to become pregnant; 5. Organ transplant patients including kidney transplantation; 6. Those who have been treated with hormones, immunosuppressants, or cytotoxic drugs within 3 months; 7. Those who have been treated with other Chinese Medicines and similar proprietary Chinese Medicines within half a month; 8. Those who are allergic to this drug; 9. Those who cannot cooperate, including all kinds of mental patients; 10. Participants in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
24h proteinuria change value;

Secondary

MeasureTime frame
eGFR(estimated glomerular filtration rate) chang value;Urine protein-creatinine ratio;Urine red blood cell count;Albumin;Nutritional Assessment Form (SGA);Symptom Burden Assessment Form (LUSS);

Countries

China

Contacts

Public ContactHe Qiang

Zhejiang Provincial People's Hospital

qianghe1973@126.com+86 13588870088

Outcome results

None listed

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