OBJECTIVETo observe the clinical efficacy of the "water-pathogen" theory-based Juanyin Tongluo Recipe (JTR) in the treatment of varicocele (VC) complicated with oligozoospermia and its effects on the semen parameters, sperm morphology, sperm DNA fragmentation index (DFI) and testis volume of the patient.METHODSNinety-two VC patients complicated with oligozoospermia were randomly assigned to receive JTR (n = 47) and Maizhiling Tablets (the control group, n = 45), respectively, both for three months, followed by comparisons of the clinical effects, total sperm count, sperm motility, percentages of progressively motile sperm (PMS) and morphologically normal sperm (MNS), sperm DNA fragmentation index (DFI) and testis volume of the patients before and after medication, and the pregnancy rate after treatment between the two groups.RESULTSThe total rate of effectiveness was significantly higher in the JTR than in the control group (87.23% vs 68.89%, P < 0.05). Compared with the baseline, the patients showed dramatic improvement after treated with JTR in the sperm count ([16.35 ± 3.52] vs [43.82 ± 6.02] ×106, P < 0.05), sperm motility ([17.37 ± 6.76]% vs [36.68 ± 11.32]%, P < 0.05), PMS ([13.42 ± 5.62]% vs [31.03 ± 7.47]%, P < 0.05), MNS ([1.91 ± 0.13]% vs [4.06 ± 0.11]%, P < 0.05), and sperm DFI ([43.32 ± 7.84]% vs [26.98 ± 6.87]%, P < 0.05), and even better than in the control group (sperm count [15.78 ± 3.84] vs [31.53 ± 5.62] ×106, P < 0.05; sperm motility [19.41 ± 6.24]% vs [31.32 ± 9.73]%, P < 0.05; PMS [14.01 ± 4.98]% vs [20.71 ± 6.49]%, P < 0.05; MNS [1.88 ± 0.14]% vs [3.12 ± 0.09]%, P < 0.05; sperm DFI [41.42 ± 9.62]% vs [34.13 ± 5.73]%, P < 0.05; sperm DFI, P < 0.05). And the rate of natural pregnancy was significantly higher in the JTR group than in the control (40.43% vs 20%, P < 0.05). No statistically significant difference, however, was observed in the testis volume before and after treatment between the JTR group ([11.53 ± 1.24] vs [10.89 ± 1.17] ml, P > 0.05) and the control ([10.94 ± 1.34] vs [10.65 ± 1.52] ml, P > 0.05).CONCLUSIONJuanyin Tongluo Recipe can increase the total sperm count, sperm motility, percentages of PMS and MNS and sperm DFI, and improve the rate of natural pregnancy in VC patients complicated with oligozoospermia.