RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-60
SponsorThe University of Hong Kong
About this trial
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?
The investigators will compare people taking the Lingzhi supplement to those who do not receive any treatment (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 participants in the waitlist group)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LingZhi capsule
DrugLingzhi-containing capsules (CP003) is a Chinese Medicine nutritional supplement manufactured by Chinese Pharm Co., Ltd, containing: wild red ganoderma extract, ganoderma spore powder (99.9% broken-wall), β-nicotinamide mononucleotide (NMN), wild yellow ganoderma extract, wild green ganoderma extract, wild purple ganoderma extract, wild white ganoderma extract, wild black ganoderma extract
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Waitlist groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean difference in Chalder Fatigue Score
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue
Time frame
From baseline to 6 weeksSecondary outcomes
1
Mean difference in Chalder Fatigue Score
Likert score 0-4 for 11 items, ranging 0-44, with higher scores indicating greater fatigue
Time frame
From baseline to 12 weeks2
Mean difference in 36-Item Short-Form Health Survey
ranging 0-100, with higher scores indicating better health status
Time frame
from baseline to 6 week and 12 week3
Mean difference in Fatigue Severity Score
Likert score 1-7 for 9 items, ranging 9-63, where higher scores indicate more severe fatigue
Time frame
from baseline to 6 week and 12 week4
mean difference in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form 7A survey
a 5-point Likert scale of 7 items, ranging 0-35, with higher scores indicating greater fatigue
Time frame
from baseline to 6 week and 12 weekOther outcomes
1
Change in serum markers
for inflammation, immunity and oxidative aging
Time frame
From baseline to 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Innovation and Technology Commission, Hong Kong
Collaborator
Source ClinicalTrials.gov