Effect of herbal preparation HemoHIM on fatigue level and exercise performance: A randomized, placebo-controlled, double-blind, and parallel clinical trial

Introduction: The herbal preparation HemoHIM, which is a mixture of traditional Korean medicinal plants, has been proven effective in enhancing exercise performance and reducing fatigue levels in mice. Therefore, this study aimed to evaluate the effect of HemoHIM on fatigue levels and exercise performance in healthy human adults. Methods: Ninety-six adults with fatigue were recruited for this study. In visit 1, maximal oxygen consumption was measured using a cycle ergometer test to assess eligibility. Participants were randomly assigned to the HemoHIM group (HG, n = 48) or the placebo group (PG, n = 48) in visit 2. Each participant consumed HemoHIM or a placebo twice per day for 8 weeks and visited the laboratory four times. Body composition, vital signs, dietary intake, fatigue level (fatigue severity scale, [FSS]), cardiorespiratory endurance, muscle strength, blood biomarkers, and adverse events were measured at each visit. Results: HemoHIM significantly decreased the FSS scores compared to that of the PG at visit 3 (P=.019); this decrease was maintained until visit 4 (P=.002). The exercise distance to exhaustion in the HG significantly increased compared to that in the PG (P=.040). HemoHIM significantly increased lactate and creatinine levels immediately after the ergometer test (lactate P=.011, creatinine P=.019) and 30 min after the test (lactate P=.036, creatinine P=.002) compared to that in the PG. Conclusion: This study demonstrated that HemoHIM reduced fatigue levels and improved exercise duration. The findings may have potential applications in the nutritional supplement industry in the future. Trial registration: This study was registered at the Clinical Research Information Service: KCT0004905.