Study design and test product
The study was designed as a randomized, double‐blinded, placebo‐controlled clinical trial and was performed at the Global Medical Research Center, Seoul, Korea, from September 2021 to April 2021. The study was conducted for 24 weeks and included a total of five visits for each participant (screening, week 0, week 8, week 16, and week 24). The permitted window periods were ±7 days for week 8, 16, and 24.The active ingredient of the test product, BLH308, was a PLE formulation of green tea and sophora fruit extract, both of which are known for their anti‐inflammatory and anti‐oxidant properties. These extracts were formulated in a 2:1:1 compounding ratio, respectively, considering the contents of tannic acid in PLE (ca. 12.5%), epigallocatechin‐3‐gallate (EGCG, ca. 50%) in green tea extract, and sophoricoside (ca. 3%) in sophora fruit extract. The information regarding the test and placebo products is shown in Table 