[Prospective, multi-centered, randomized and controlled trial on effect of Shenle Capsule in treating patients with IgA nephropathy of Fei-Pi qi-deficiency syndrome]

Abstract

Objective: To observe the effect and safety of Chinese compound Shenle Capsule (SC) in treating IgA nephropathy patients of Fei-Pi qi-deficiency syndrome (FPQD).

Methods: A prospective, multi-centered, randomized, double-blinded, double-mimetic, controlled trial was conducted in 70 IgA nephropathy patients of FPQD syndrome, who were randomly assigned to two groups treated with SC and fosinopril respectively for 12 weeks. The changes of TCM syndrome score, 24 h urine protein quantity (UP), serum creatinine (SCr), hepatic function before and after treatment and the adverse reaction were observed.

Results: Compared with those before treatment, the level of UP and the TCM syndrome scores decreased significantly in both groups (P < 0.05 or P < 0.01), while the level of albumin increased significantly after treatment, and the level of total cholesterol, triglycerid and renal function remained unchanged (P > 0.05). There was no significant difference in all the above parameters between the two groups. According to the curative criterion for Chinese medicine and Western medicine, the total effective rate was 83.3% and 66.7% respectively in the SC treated patients, 82.4% and 58.8% respectively in the fosinopril treated patients, showing insignificant difference between them. In addition, no severe adverse event was found.

Conclusion: SC treatment showed effects similar to that of fosinopril in reducing proteinuria and improving TCM syndrome in IgA nephropathy patients of FPQD syndrome, and could be well tolerated by patients.