Health Canada Clears Clinical Trial Protocol for Redsenol-1 Ginseng Study on Cancer-Related Fatigue

Canada Royal Enoch Phytomedicine, a specialist in ginseng and ginsenosides research and application, announced that Health Canada has completed a review of amendments made to a clinical trial on Resenol-1 Plus Noble Ginsenoside Capsules, an investigational natural health product, and its roles in cancer-related fatigue.

The updated clinical trial protocol will allow the study, which began in 2022, to continue under a revised research framework. Cancer-related fatigue is a common challenge faced by many cancer patients, particularly during and after anticancer treatments such as chemotherapy and radiotherapy, and can continue to affect daily functioning and quality of life. The study aims to further explore the potential of Redsenol-1 Plus.

The study has been actively conducted since 2022, with some participants having completed treatment, providing valuable data and operational experience. As the study has advanced, the research team has continued to refine the study design and participant access based on practical experience gained during the clinical trial.

Health Canada’s review and no objection notification regarding the clinical trial amendment provides an updated framework for the continuation of the study, and may provide more eligible cancer patients with an opportunity to participate.

Redsenol-1 contains 16 rare ginsenosides derived from ginseng, and is listed on the U.S. National Cancer Institute’s Drug Dictionary.

“Cancer-related fatigue is a long-term challenge faced by many patients, yet it is often overlooked,” said Peihua Yu, CEO of Canada Royal Enoch Phytomedicine. “Since the study began, we have continued to advance the clinical trial and learn from practical experience gained throughout the research process. Health Canada’s review of the clinical trial amendment represents an important step in the continued development of this study. We look forward to generating additional scientific data through rigorous clinical research.”