RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue

A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue

The goal of this clinical trial is to test if a Lingzhi supplement (CP003) helps people with chronic fatigue or post-COVID fatigue feel better. It will also check if the supplement is safe to use. The main questions it aims to answer are:

Does the Lingzhi supplement reduce fatigue symptoms? Is it safe to take? How does it affect the body's immune system and inflammation?

Researchers will compare people taking the Lingzhi supplement to those who don't take anything (waitlist group) to see if it works.

Participants will:

• Take 5 capsules once daily for 6 weeks (or wait to start treatment if in waitlist group)
• Visit the clinic 2 times for blood tests (before and after taking the supplement)
• Complete questionnaires 3 times about their fatigue and quality of life (4 times questionnaires for waitlist group)

Inclusion Criteria:

• Meet the Fukuda diagnostic definition of CFS/ME or have persisting fatigue after the infection of SARS-CoV-2
• Are able to complete a 6-week course of intervention;
• Able to complete the online validated fatigue surveys.

Exclusion Criteria:

• Have participated in any type of complements or herbal medicine within the past six months;
• Have serious medical conditions that might limit their participation in this intervention;
• Diagnosed with acute inflammation;
• Are pregnant or are planning a pregnancy in the next 3 months.