At a glance
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A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
In Brief
A clinical study evaluating Redsenol-1 Plus and Placebo for Fatigue and Cancer, Treatment-Related. Not yet recruiting, targeting 72 participants across 1 site.
Detailed Summary
The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults. The change in the severity of CRF from baseline at week 12 will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, and compared between Redsenol-1 Plus and placebo groups. Additionally, the safety and tolerability of Redsenol-1 Plus, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).
Study Details
Timeline
Interventions
Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).