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RecruitingNCT06739720Updated Sep 21, 2026

RCT of Efficacy and Safety of CP003 on CFS/ME or Post COVID-19 Fatigue

A Phase 2/3 interventional study of LingZhi capsule in Chronic Fatigue Syndrome (CFS) and Post-COVID ME/CFS, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by The University of Hong Kong · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.

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Phase
Phase 2/3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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?

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)
02

Conditions studied

  • Chronic Fatigue Syndrome (CFS)
  • Post-COVID ME/CFS
03

In context

Fatigue Syndrome, Chronic

264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.

This study's planned enrollment of 130 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.

Browse Fatigue Syndrome, Chronic studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Participants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.

    Drug: LingZhi capsule

  • No intervention
    Waitlist group

    Participants initially wait for 6 weeks after randomization without intervention. After the waiting period, participants receive the same CP003 supplement regimen (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.

Interventions

  • Lingzhi-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

06

What researchers measure

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 weeks

Secondary 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 weeks

  2. 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 week

  3. 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 week

  4. 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 week

  5. Mean difference in hospital anxiety and depression scale

    ranging 0-21, with higher scores indicating more severe symptoms

    Time frame: from baseline to 6 week and 12 week

  6. Mean difference in Pittsburgh sleep quality index

    ranging 0-21, with higher scores indicating worse sleep quality

    Time frame: from baseline to 6 week and 12 week visit.

Other outcomes

  1. Change in serum markers

    for inflammation, immunity and oxidative aging

    Time frame: From baseline to 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

Publications

  • Xun Y, Fong TL, Chen G, Feng Y, Chan L, Wang N. Effectiveness and Safety of a Supplement Containing a Pharmacologically Active Basidiomycete Mushroom for Chronic Fatigue and Post-COVID-19 Fatigue Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 20;15:e82633. doi: 10.2196/82633. PubMed 41558017 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in Jan 2026, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2024
First posted
Dec 18, 2024
StartActual
Jan 2, 2025
Primary completionActual
Jan 15, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06739720
Collaborators
Innovation and Technology Commission, Hong Kong
Responsible party
Sponsor
First posted
Dec 18, 2024
Start date
Jan 2, 2025
Primary completion
Jan 15, 2026
Completion
Dec 31, 2026 (estimated)
Last update
Sep 21, 2026

Study contacts

TUNG LEONG FONG
Contact
tlfong@hku.hk
+852 5660 4020
Yunqing Xun
Contact
Windqing@hku.hk
+852 3917 6515

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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