Minimal change disease
Conditions
Interventions
Experimental group:Bupi Yishen granules and Shenling Baishu capsules
Placebo controlled group:Bupi Yishen granules Placebo and Shenling Baishu capsules Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 14 to 80 years old 2.Minimal change disease confirmed by renal biopsy 3.The 24-hour urinary protein excretion increase by 50% during the past 3 months, or the 24-hour urinary protein exceed 1gram/24h, or urinary-albumin-creatinine ratio exceed 1gram/gram 4.Written informed consent is gained;
Exclusion criteria
Exclusion criteria: 1.Pregnancy or nursing, or has a pregnancy willing during the study period 2.Minimal change of renal pathology caused by secondary factors; 3.Patients with other uncontrolled severe diseases, including: severe heart failure (NYHA grade IV), active infectious diseases (e.g. tuberculosis, hepatitis), hematopoietic system abnormalities or tumors (e.g. lymphocyte proliferation), water, electrolyte and acid-base balance disorders, history of primary or secondary immunodeficiency and hypersensitivity, history of mental illness, level of alanine aminotransferase or aspartate aminotransferase is three times higher than the upper limit of normal, HIV serological test positive, Blood white blood cell count, hemoglobin level, platelet count is lower than the lower limit of normal value, or other server abnormalities of laboratory tests; 4.Has any contraindication of rituximab and/or glucocorticoids; 5.Allergy or intolerance to investigational agent; 6.Participating in other clinical trials; 7.History of taking herbal regimens in the past two weeks at the enrollment; 8.Considered by the investigators that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of recurrent cases;Changes of urinary protein level;Serum creatinine level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average days from induced remission to first relapse;Cumulative days of glucocorticoid use;Cumulative does of glucocorticoids; | — |
Countries
China
Contacts
Public ContactLiu Xusheng
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed