Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 19, 2025
Date Accepted: Dec 9, 2025
Effectiveness and safety of CP003 on chronic fatigue and post-COVID fatigue syndrome: A Study protocol for a randomized controlled trial
ABSTRACT
Background:
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is characterized by persistent, unexplained exhaustion unalleviated by rest, with pathophysiology distinct from underlying medical conditions. The diagnostic complexity arises from symptom overlap with other disorders and the absence of definitive biomarkers, contributing to limited therapeutic options in current medicine. Lingzhi, a pharmacologically active basidiomycete mushroom, has been empirically utilized in Traditional Chinese Medicine (TCM) for two millennia. The study has a dual focus: (1) systematically evaluating its efficacy and safety in managing chronic fatigue and post-COVID fatigue syndromes, and (2) elucidating its clinical associations with inflammatory, immune, and oxidative stress biomarkers to uncover potential therapeutic mechanisms.
Objective:
The study has a dual focus: (1) systematically evaluating its efficacy and safety in managing chronic fatigue and post-COVID fatigue syndromes, and (2) elucidating its clinical associations with inflammatory, immune, and oxidative stress biomarkers to uncover potential therapeutic mechanisms.
Methods:
This randomized, waiting list-controlled trial will enroll 130 participants in Hong Kong, equally allocated (1:1) to either the CP003 intervention group or a waitlist control group. The intervention period spans 6 weeks, followed by a 6-week follow-up phase to assess sustained effects. The trial data will be managed using REDCap, analyzed via intention-to-treatment with IPW for missing data, assessed through generalized linear regression (adjusted for covariates and interaction terms) at 6/12 weeks, and supplemented by subgroup/sensitivity analyses in R, with results reported as mean differences (95% CI) and p<0.05 considered significant.
Results:
This study will provide experimental data on effectiveness and safety of CP003 on chronic fatigue and post-COVID fatigue syndrome.
Conclusions:
This study will provide experimental data on effectiveness and safety of CP003 on chronic fatigue and post-COVID fatigue syndrome. Clinical Trial: ClinicalTrials.gov NCT06739720. Registered on 16/12/2024.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.