To evaluate the clinical efficacy and safety of Shenkangning Capsule in the treatment of kidney yang deficiency syndrome.Methods:A total of 360 patients with kidney yang deficiency in the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine from May 2018 to October 2018 were selected as the research objects and were randomly divided into 3 groups：a control group，a combined treatment group and a zinc gluconate group.The 3 groups were given the corresponding plan for treatment.The nocturnal urine volume，frequency(daily urine)，urinary incontinence and urgency were recorded before treatment，4 weeks after treatment and 8 weeks after treatment.The quantitative score of traditional Chinese medicine(TCM)syndrome was performed，and the clinical total effective rate，disappearance rate of single symptom，quality of life and adverse reactions of the 3 groups were evaluated.Results:After treatment，the scores of TCM syndrome of nocturia，urinary incontinence，frequency of urination and urgency in 3 groups were better than those before treatment(P<0.01).The total effective rates were as follows：74.34% in the combined treatment group，59.32% in the zinc gluconate group and 56.25% in the control group after 4 weeks of treatment，and 92.92% in the combined treatment group，77.12% in the zinc gluconate group and 63.39% in the control group after 8 weeks of treatment.Conclusion:Shenkangning Capsule combined with medication in the treatment of urinary disease with kidney yang deficiency has significant curative effect，can significantly reduce the number of night urine and daily urine，improve the symptoms of urinary incontinence，frequency and urgency，improve the quality of life of patients，which is safe and reliable.