A domestic research team announced clinical findings that SAGX, a functional ingredient based on Danshen extract, is more effective than saw palmetto in improving lower urinary tract symptoms (LUTS) and quality of life, as well as erectile function, associated with benign prostatic hyperplasia.
Director Kim Eun-young of Gangnam Guard Urology Clinic and a research team from the College of Pharmacy at CHA University said in a clinical study involving men with lower urinary tract symptoms (LUTS) that SAGX showed superior improvement compared with saw palmetto, the existing standard health functional food ingredient. The findings were published in the latest issue of the international journal "Nutrients."
To compare the effects of SAGX and saw palmetto, the research team conducted a 12-week randomized, double-blind, parallel-group clinical trial.
According to the study, SAGX lowered the International Prostate Symptom Score (IPSS)—a key indicator for assessing urinary symptoms in patients with benign prostatic hyperplasia—by an average of 4.6 points, an improvement about 7.7 times greater than the saw palmetto group (0.6-point decrease). Generally, a reduction of 3 points or more in IPSS is considered a clinically meaningful improvement.
The degree of improvement in storage symptoms such as frequent urination, nocturia, and urgency was also about 13 times greater than in the saw palmetto group. Quality of life improved significantly as well, and an improvement in erectile function was confirmed. The research team explained that the improvement in erectile function may be the result of a mechanism related to vascular function recovery.
The research team analyzed that these effects were based on activation of cellular energy metabolism through mitochondrial function recovery and strengthening of the antioxidant system. Tanshinone, the key active component of SAGX, was found to restore mitochondrial function and activate the Nrf2 pathway, the cell's antioxidant defense system, thereby reducing reactive oxygen species and promoting the production of antioxidant enzymes.
SAGX is an individually approved health functional food ingredient that received recognition in 2023 from the Ministery of Food and Drug Safety for the functionality of "may help maintain prostate health."
In the nonclinical study that formed the basis for the functionality recognition, effects such as reduced prostate weight and improved histological damage were confirmed in an animal model of androgen-induced prostate enlargement, and the mechanism of activating the antioxidant defense system to reduce cellular damaging substances was also identified.
However, as this study was conducted as a pilot study, the research team said larger-scale clinical trials are needed to further verify the efficacy and safety of SAGX.
Previously, G&BioSolution developed and launched the prostate health functional food "Alpha Switch SAGX." Park Ji-hyun, chief director of Seoul NewGen Urology Clinic, who participated in the product development, said, "While existing treatments have focused on suppressing androgen signal transduction, SAGX's biggest differentiator is that it addresses the root causes of cellular damaging substances, chronic inflammation, and mitochondrial dysfunction."
Park said, "Given the mechanism of restoring mitochondrial function, it may have applications not only for prostate health but also in areas related to aging, such as metabolic diseases, cardiovascular health, and cognitive function," adding, "We expect that future men's health management will shift from hormone suppression to normalization of cellular energy metabolism and the antioxidant system."
References
Nutrients (2026) DOI: https://doi.org/10.3390/nu18111752