Diabetic kidney disease
Conditions
Interventions
Probiotic Group:Probiotics combined with Tangshen Qushi formula placebo plus usual care
Western medicine conventional treatment group:Tangshen Qushi formula placebo combined with probiotics placebo pius usual care
Tangshen Qushi formula Group:Tangshen Qushi formula combined with probiotics placebo pius usual care
Probiotics combined with Tangshen Qushi formula Group:Probiotics combined with Tangshen Qushi formula plus usual care
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years old; 2) Meet the diagnostic criteria of diabetic nephropathy; 3) Glomerular filtration rate eGFR in the range of 15-60 mL /min /1. 73 ? and fluctuation range = 30% in the 3 months before enrollment; 4) Voluntary informed consent. Diagnostic criteria for diabetic nephropathy: meet the diagnostic criteria for diabetes mellitus established by the American Diabetes Association in 2020, i.e., a clear history of diabetes mellitus, as well as the existence of a causal relationship with changes in urinary albumin and renal function, and the exclusion of other primary and secondary glomerular and systemic diseases, and meet one of the following conditions: (1) Random urinary albumin- to-creatinine ratio (UACR) = 30 mg/g or urinary albumin excretion rate (UAER) = 30 mg/24h, and repeated examinations within 3 to 6 months of UACR or UAER, with 2 out of 3 times meeting or exceeding the threshold value; other interfering factors such as infection were excluded; (2) eGFR <60 mL/min/1.73m2 for no less than 3 months; (3) Renal puncture biopsy consistent with DKD pathologic changes.
Exclusion criteria
Exclusion criteria: 1) taking antibiotic medication within 30 days or a probiotic product within 14 days; 2) Immediate need for dialysis treatment; 3) Being treated with hormones or immunosuppressants; 4) Combination of active malignant tumors; 5)Severe cardiac arrhythmia, severe heart failure, NYHA class III and above; 6). pregnant or lactating patients; 7). Those who are unable to cooperate, such as psychiatric patients; 8). patients who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual eGFR slope; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary albumin creatinine ratio;HbA1c%;Urinary protein creatinine ratio;Score of dampness syndrome scale of Chinese medicine;Renal function set (serum creatinine, blood urea nitrogen, serum uric acid, serum albumin);Blood lipids profile (triglycerides, cholesterol, high- and low-density lipoprotein cholesterol);The survival time of renal composite endpoint events; | — |
Countries
Chia
Contacts
Public ContactXusheng Liu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed