Clinical trial NCT06739720: RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue
Official title: A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Chronic Fatigue Syndrome (CFS)
Post-COVID ME/CFS
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Innovation and Technology Commission, Hong Kong
First posted: 2024-12-18
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned in a 1:1 ratio to either the intervention group or the waitlist group. The intervention group receives CP003 capsules (5 capsules once daily) for 6 weeks. The waitlist group undergoes a 6-week waiting period without any treatment.
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Mean difference in Chalder Fatigue Score
timeFrame: From baseline to 6 weeks
Secondary outcomes:
measure: Mean difference in Chalder Fatigue Score
timeFrame: From baseline to 12 weeks
measure: Mean difference in 36-Item Short-Form Health Survey
timeFrame: from baseline to 6 week and 12 week
measure: Mean difference in Fatigue Severity Score
timeFrame: from baseline to 6 week and 12 week
measure: mean difference in (PROMIS) Short Form Fatigue 7A survey
timeFrame: from baseline to 6 week and 12 week
measure: Mean difference in hospital anxiety and depression scale
timeFrame: from baseline to 6 week and 12 week
measure: Mean difference in Pittsburgh sleep quality index
timeFrame: from baseline to 6 week and 12 week visit.
Other outcomes:
measure: Change in serum markers
timeFrame: From baseline to 6 weeks
Locations:
city: Hong Kong
country: Hong Kong
facility: Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
Study officials:
References: