An Exploratory Single‐Arm Clinical Trial on Eucommia Ulmoides Leaf Extract Effects on Blood Pressure, Oxidative Stress, and Atrial Natriuretic Peptide (ANP) in Individuals With and Without Chronic Kidney Disease

Eucommia ulmoides (Tochu) has been shown to possess a variety of beneficial effects on profiles affecting the onset of lifestyle- or aging-related diseases, such as hypertension, diabetes, dyslipidemia, or obesity. This exploratory single-arm clinical study was conducted on a total of 17 participants including those with mild chronic kidney disease (CKD) (<i>n</i> = 9), who were administered a tablet product containing Tochu leaf extract for a short period (median: 33 days), to investigate its effects on blood pressure or related clinical markers. Mean systolic blood pressure (SBP) of all the participants significantly decreased from 128.3 ± 12.3 mmHg at the start to 123.8 ± 10.2 mmHg at the end of the administration (<i>p</i> < 0.05). Analysis of CKD patients alone, however, revealed that SBP, to a greater extent, decreased from 130.7 ± 12.9 mmHg to 121.2 ± 10.7 mmHg (<i>p</i> < 0.01), while the change in non-CKD patients was not significant. Furthermore, SBP decrease in CKD patients with hypertension (<i>n</i> = 7) alone was also significant and comparable. Mean blood oxidative stress index of all participants was decreased from 300.2 ± 76.7 U.CARR to 285.9 ± 63.0 U.CARR (<i>p</i> < 0.05), while median atrial natriuretic peptide (ANP) of all the participants was increased from 8.1 (5.0-9.6) pg/mL to 8.8 (5.8-12.1) pg/mL (<i>p</i> < 0.05). Our findings suggested that Tochu-derived components may have potential therapeutic benefit at earlier stages in CKD, which could fill the gaps in currently underserved opportunities for prevention or intervention. <b>Trial Registration:</b> UMIN Clinical Trials Registry: UMIN000050727.