Health Canada Clears Updated Clinical Trial Protocol for Redsenol-1 Plus
核心洞察
Health Canada completed its review of a Clinical Trial Amendment for Redsenol-1 Plus (搜索) and indicated it has no objection to the proposed study.
The amendment sets a revised research framework for the ongoing cancer-related fatigue (搜索) trial, which began in 2022 and has already produced participant data.
Redsenol-1 Plus (搜索) is an oral botanical formulation containing sixteen rare ginsenosides and is listed in the NCI Drug Dictionary.
Canada Royal Enoch Phytomedicine Ltd. (搜索) said Health Canada has completed its review of a Clinical Trial Amendment and supporting materials for Redsenol-1 Plus (搜索) Noble Ginsenoside Capsules and has indicated it has no objection to the proposed study. The updated protocol allows the trial in cancer-related fatigue (搜索) (CRF) to continue under a revised research framework, which the company said may give more eligible patients with CRF an opportunity to participate.
The study has been running since 2022, with some participants having completed it, providing clinical data and operational experience. The research team has refined the study design and participant access based on that experience. Cancer-related fatigue (搜索) is common among cancer patients, particularly during and after chemotherapy and radiotherapy, and can affect daily functioning and quality of life.
Redsenol-1 Plus (搜索) is an oral botanical formulation containing sixteen rare ginsenosides derived from ginseng, including Rg3 (R, S), Rh1 (S, R), Rh2 (R, S), Rk1, Rk3, Rg5, Rh3, Rh4, Rk2, aPPD (S, R) and aPPT (S, R). The product is listed in the NCI Drug Dictionary of the U.S. National Cancer Institute. The trial is registered on ClinicalTrials.gov under identifier NCT05664009.
Source: Health Canada Clears Updated Clinical Trial Protocol for Redsenol-1 Plus