Study to Evaluate the Effect of ''Tangshen Fang'' combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with Diabetes Nephropathy: a Clinical Trial on Constructing a Novel Paradigm of Integrated Traditional Chinese and Western Medicine in the Treatment

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Experimental group:Tangshen Fang+Standard Western Medicine±Traditional Chinese Medicine;Control group:Standard Western Medicine±Traditional Chinese Medicine; CONDITION: Type 2 diabetes kidney disease PRIMARY OUTCOME: Change in eGFR levels from baseline to week 24; SECONDARY OUTCOME: Urine protein/creatinine ratio (UACR) from baseline at 24 weeks;Change in body weight from baseline to week 24;Change in body blood pressure(systolic and diastolic) from baseline to week 24;Change in fasting lipid profile (TC, LDL‐C, HDL‐C, TG) from baseline to week 24;Change in fasting plasma glucose from baseline to week 24;Change in HbA1c from baseline to week 24;Improvement in TCM symptoms(evaluated by TCM symptom assessment score)from baseline to week 24;Improvement in quality of life from baseline to week 24;Change in waist circumference from baseline to week 24; INCLUSION CRITERIA: 1. Aged 18‐75 years, no gender limit; 2. Clearly diagnosed type 2 diabetes; Glycosylated hemoglobin <=11%; 3. Diabetic kidney disease: eGFR: 25 75ml/min/(1.73m^2) with UACR>=30mg/g, or eGFR: 25 <60 ml/min/(1.73m^2) with UACR<30mg/g; And last for more than 3 months; 4. TCM syndrome differentiation mainly consists of Qi and Yin deficiency with blood stasis; 5. Sign informed consent and cooperate with follow‐up visits.
Epistemonikos ID: 8fc477a846049d01429fbf978f01f4e2bdc03c25
First added on: Feb 20, 2024