Abstract
OBJECTIVES: To examined the efficacy and safety of Peng's Shengjing recipe in treating asthenospermia with deficiency and failure of kidney yang. The traditional Chinese medicine (TCM) Peng's Shengjing recipe might have benefits in treating male asthenospermia. METHODS: This randomized, positive drug-controlled, single-blind pilot study enrolled outpatients from the Third Department of Traditional Chinese Medicine Surgery, Shanghai University of Traditional Chinese Medicine, Shanghai, China, between April 2020 and September 2020. A total of 99 participants were randomized to Shengjing recipe (n=50) and Xuanju capsule (n=49). They were treated for 12 weeks. The primary endpoint was routine semen examinations, including the percentage of sperm motility rated grade A, A+B, and A+B+C, and the clinical effective rate. The secondary endpoints were the levels of gonadotropins. RESULTS: The A grade sperms (18.9% versus [vs.] 13.9%, p=0.030) and A+B grade sperms (42.9% vs. 32.7%, p<0.001) were higher in the Shengjing recipe group than the Xuanju capsule group. The effective rates were 68% and 53.1% in the Shengjing recipe and Xuanju capsule groups (p=0.128). No safety signals were observed. CONCLUSION: Peng's Shengjing recipe improves the quality of sperms and is effective in treating clinical asthenospermia of deficiency of kidney yang. The treatment was well tolerated, without obvious hepatorenal toxicity.Chinese Clinical Research Registry No.: ChiCTR2000030845.