SHPro®(mixture of Angelica gigas and Astragalus membranaceus) in men with lower urinary tract symptoms: A randomized, double-blind clinical trial

Abstract

Purpose: A preclinical trial confirmed that Angelica gigas and Astragalus membranaceus had a curative effect on benign prostatic hyperplasia (BPH). Therefore, this study aimed to investigate the effects of this compound in patients with BPH symptoms. Materials and Methods: Subjects were divided into the treatment and control groups. They underwent four visits, and medication was initiated from the 2nd visit onwards, with a total of 12 weeks of intake. The endpoints were the International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), prostate-specific antigen level, testosterone, dihydrotestosterone, maximal urinary flow rate, residual urine volume, and subjective evaluation improvement. Safety tests included clinical pathology tests and checking for adverse reactions. Results: A total of 39 patients from the treatment group and 45 from the control group were included in the efficacy analysis. After 12 weeks, a significant improvement was seen in IPSS total score (p=0.0219) and incomplete emptying score (p=0.0007). Furthermore, there were statistically significant improvements in the IIEF total score, erectile function, sexual desire, intercourse satisfaction, and overall satisfaction in the treatment group. The subjective improvement evaluation also showed a significant improvement (p=0.0143). Ten cases of mild adverse events were reported, including gastrointestinal problems, skeletal pain, dermatitis, and others. However, no severe adverse reactions were observed, and it was unlikely that these were related to the test product. Conclusions: After taking the trial product (SHPro((R))) for 12 weeks, the total and incomplete emptying IPSS improved, as did the IIEF, which indicated subjective improvements. And its safety was confirmed.