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RECRUITING
NCT05664009
PHASE2

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2023-05-30

Completion Date

2025-06

Last Updated

2024-04-05

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Redsenol-1 Plus

Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).

OTHER

Placebo

Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

Locations (1)

KGK Science Inc.

London, Ontario, Canada