Chronic Fatigue Syndrome (CFS), Post-COVID ME/CFS
Conditions
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)
Interventions
DRUGLingZhi capsule
Lingzhi-containg 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 sesame extract
Sponsors
Innovation and Technology Commission, Hong Kong
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in Chalder Fatigue Score | From baseline to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean difference in hospital anxiety and depression scale | from baseline to 6 week and 12 week |
| Mean difference in Chalder Fatigue Score | From baseline to 12 weeks |
| Mean difference in 36-Item Short-Form Health Survey | from baseline to 6 week and 12 week |
| mean difference in (PROMIS) Short Form Fatigue 7A survey | from baseline to 6 week and 12 week |
| Mean difference in Pittsburgh sleep quality index | from baseline to 6 week and 12 week visit. |
| Mean difference in Fatigue Severity Score | from baseline to 6 week and 12 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum markers | From baseline to 6 weeks | for inflammation, immunity and oxidative aging |
Countries
Hong Kong
Contacts
Primary ContactTUNG LEONG FONG
Backup ContactGuang Chen
Outcome results
None listed