Objective:To investigate the efficacy and safety of black tomato concentrated sauce in the treatment of benign prostatic hyperplasia(BPH) with lower urinary tract symptoms(LUTS).Methods:An open, randomized and controlled trial was conducted, and 150 BPH patients with LUTS were randomly assigned to three groups: experimental group(60 cases), placebo group (45 cases) and positive control group(45 cases) in the Department of Urology, Lanzhou University Second Hospital from December 2018 to September 2020.Inclusion criteria: age≥50 years old; first diagnosis of BPH, or interrupted medical treatment of BPH for more than 1 month; maximum urinary flow rate (Q max) <15ml/s; prostate volume (PV)≥20ml; IPSS≥8, QOL≥2. Exclusion criteria: lower urinary tract obstruction not caused by BPH, post-void residual urine volume(PVR) >250 ml; history of acute urinary retention in the last 3 months; prostate nodules and suspected prostate cancer were revealed by digital rectal examination and transrectal B-ultrasoundor; prostate-specific antigen (PSA)≥10 ng/ml; neurogenic bladder, perivous history of bladder, prostate, or urethra operations; suffering from serious heart, lung, liver, kidney and other diseases. The patients in the experimental group were orally treated with black tomato concentrated sauce(30 g/once, 3 times/day). The patients in the placebo group were orally administrated with placebo. In the positive control group, the patients with PV≤30ml were orally treated with tamsulosin(0.2mg/once, 1 time/day), the patients with PV>30ml were orally administrated with tamsulosin and finasteride(5 mg/once, 1 time/day). All enrolled patients were treated for 3 months. At the end of third month, the IPSS, QOL, PV, PVR, Q max, average urinary flow rate(Q ave), total PSA(tPSA), free PSA (fPSA), testosterone(TST) and the incidence of adverse reaction were assessed. Results:128 of 150 cases, including 52 cases in experimental group, 36 cases in placebo group and 40 cases in positive control group, completed the study, the rest was excluded due to not take medication regularly and fail to follow-up. There were no significant differences in baseline parameters among experimental group, placebo group and positive control group ( P>0.05) in age[(63.21±8.61) vs.(62.36±6.32) vs. (63.94±7.78)years old], body mass index[(23.74±3.17) vs. (23.94±3.09) vs. (24.26±2.91)kg/m 2], IPSS[(17.5±6.6) vs. (15.4±5.8) vs. (17.9±6.8)], QOL[4.0(3.0, 4.0) vs. 4.0(3.0, 4.5) vs. 4.0(3.0, 5.0)], Q max [(8.60±3.04) vs. (9.13±2.92) vs. (9.58±3.26) ml/s], Q ave[(4.39±1.69) vs. (4.66±1.76) vs. (4.88±1.60)ml/s], PV [32.00(25.55, 45.40)vs. 30.00(24.45, 38.35)vs. 34.80(27.65, 56.65)ml], PVR[23.50(8.25, 45.75) vs.5.50(0, 47.75) vs. 29.00(0, 84.00)ml], tPSA [1.53(0.89, 3.00) vs. 1.23(0.69, 1.98) vs. 2.23(0.90, 4.15)ng/ml], fPSA [0.37(0.28, 0.76) vs. 0.37(0.22, 0.52) vs. 0.54(0.30, 0.97) ng/ml] and TST[(443.64±156.32) vs. (493.97±176.16) vs. (450.89±135.08)ng/dl]. After 3 months of treatment, the IPSS in experimental group was(9.9±5.7), QOL score 2.0(2.0, 3.0), Q max(11.78±5.24)ml/s, Q ave(5.86±3.00)ml/s, tPSA 1.64(0.96, 3.32)ng/ml and TST (475.91±177.33)ng/dl, which were significantly different compared with pre-treatment( P<0.05). In positive control group, IPSS was (9.0±6.2), QOL 2.0(2.0, 3.0), Q max(11.73±4.50)ml/s, Q ave(6.11±2.53)ml/s, tPSA 1.57(0.80, 3.09)ng/ml, fPSA 0.37(0.24, 0.63)ng/ml and TST (526.11±126.88)ng/dl, which were statistically different compared with pre-treatment( P<0.01). However, there were no significant differences in all the above indexes in placebo control group compared with the baseline( P>0.05). The numerical changes of IPSS, QOL, Q maxand Q ave between experimental group and placebo group had statistically significant differences ( P<0.05). The changes of IPSS, QOL, Q max, Q ave, PV, tPSA, fPSA and TST between positive control group and placebo group had significant differences ( P<0.05). The changes of PV, tPSA and fPSA between positive control group and experimental group had statistically significant differences ( P<0.05). The incidence of adverse reactions was 5.77% (3/52, including 1 headache and 2 stomach discomfort) in experimental group, 5.56% (2/36, including 1 headache and 1 stomach discomfort) in placebo group, and 10.00%(4/40, including 1 dizzy, 1 nasal obstruction and 2 erectile dysfunction) in positive control group. And there was no statistical difference in the incidence of adverse reactions among three groups ( P>0.05). Conclusions:Black tomato concentrated sauce shows an excellent effect on patients with LUTS/BPH, and improves the quality of life with few adverse events.