Health Canada has completed its review of a Clinical Trial Amendment for Redsenol-1 Plus Noble Ginsenoside Capsules and raised no objection to the proposed study, Canada Royal Enoch Phytomedicine has announced.
The investigational natural health product is being studied as a potential support for cancer-related fatigue (CRF), a condition commonly experienced by patients during and after treatments such as chemotherapy and radiotherapy that can persist and affect daily quality of life.
The regulator's no-objection notice allows the trial to proceed under a "revised research framework" — though the announcement did not specify exactly what changed in the amended protocol.
First initiated in 2022, the study has already generated clinical data from participants who have completed it, with the research team using that experience to refine the trial design and participant access ahead of this amendment.
Redsenol-1 Plus is an oral botanical formulation containing sixteen rare ginsenosides, including Rg3, Rh1, Rh2, Rk1, Rk3, Rg5, Rh3, Rh4, Rk2, aPPD and aPPT variants derived from ginseng.
It is listed in the NCI Drug Dictionary maintained by the US National Cancer Institute.
"Cancer-related fatigue is a long-term challenge faced by many patients, yet it is often overlooked," said Dr Peihua Yu, CEO of Canada Royal Enoch Phytomedicine, adding that the amendment marks a step forward in generating further clinical evidence for the formulation.
"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.
The trial is registered on ClinicalTrials.gov under identifier NCT05664009.
