Effectiveness and safety of XiaoBai granule and Losartan Potassium for the reduction of albuminuria in patients with Chronic Glomerulonephritis (CKD stage 1-2)：a multicenter, randomized, double-blind, controlled clinical trial

OBJECTIVE: To evaluate the effectiveness and safety of XiaoBai granule and losartan potassium (LP) in patients with CGN (CKD stage 1-2). METHOSDS: Totally 160 patients who underwent CGN (CKD stage 1-2) between June, 2020 and July, 2022 in 9 hospitals in Shanghai were assigned (1:1) to treatment group (XBG + LP) and control group (XBG placebo + LP) for 6 months. The primary outcome was the change in 24-hour urinary total protein quantity (24hUTP) over 6 months. The secondary outcomes were composite of Traditional Chinese Medicine (TCM) symptom scores, renal function, and renal tubular injury signature. Meanwhile, the safety of the study was evaluated. RESULTS: Altogether 74 patients in control group and 78 patients in treatment group were included in the final analysis. Compared to the control group, the treatment group had a significant decrease in 24hUTP, improved renal function and TCMsymptom scores over the 6 months with statistically significant differences ( p ＜0.001). Besides, the 24hUTP was positively correlated with urine N-acetyl-β-D-amino glucoside (NAG) and urine retinol-binding protein(RBP) ( p ＜0.001). During the study, no side effects were observed in either group. CONCLUSION: The combination of XBG with LP was found to be safe and more effective in improving albuminuria and and protecting renal function than LP alone. Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of CGN.