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Not yet recruiting NCT06739720

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

Phase II / Phase III Interventional Chronic Fatigue Syndrome (CFS) Post-COVID ME/CFS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LingZhi capsule.
Who it may be relevant to
Registry conditions: Chronic Fatigue Syndrome (CFS), Post-COVID ME/CFS. Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug LingZhi 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

Primary outcome measures

  • Mean difference in Chalder Fatigue Score [Time frame: From baseline to 6 weeks]
Secondary outcome measures (6)
  • Mean difference in Chalder Fatigue Score [Time frame: From baseline to 12 weeks]
  • Mean difference in 36-Item Short-Form Health Survey [Time frame: from baseline to 6 week and 12 week]
  • Mean difference in Fatigue Severity Score [Time frame: from baseline to 6 week and 12 week]
  • mean difference in (PROMIS) Short Form Fatigue 7A survey [Time frame: from baseline to 6 week and 12 week]
  • Mean difference in hospital anxiety and depression scale [Time frame: from baseline to 6 week and 12 week]
  • Mean difference in Pittsburgh sleep quality index [Time frame: from baseline to 6 week and 12 week visit.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The Univ — Hong Kong

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. PMID 41558017

Identifiers

NCT: NCT06739720 · HKWC-2024-320

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗