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

A Randomized, Waitlist-controlled Clinical Study on the Efficacy and Safety of Lingzhi-containing Dietary Supplement CP003 on Chronic Fatigue and Post-COVID Fatigue

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Fatigue Syndrome (CFS); Post-COVID ME/CFS
• Intervention / Treatment: Drug: LingZhi capsule

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: TUNG LEONG FONG; Phone Number: +852 5660 4020; Email: tlfong@hku.hk
• Study Contact Backup: Name: Guang Chen; Phone Number: +852 3917 6515; Email: gchen91@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
    • Contact: TUNG LEONG FONG; Phone Number: +852 5660 4020; Email: tlfong@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
No Intervention: Waitlist group; Participants initially wait for 6 weeks after randomization without intervention. After the waiting period, they receive the same CP003 supplement regimen (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean difference in Chalder Fatigue Score	From baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Fatigue Severity Score	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 hospital anxiety and depression scale	from baseline to 6 week and 12 week
Mean difference in Pittsburgh sleep quality index	from baseline to 6 week and 12 week visit.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum markers	for inflammation, immunity and oxidative aging	From baseline to 6 weeks

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Innovation and Technology Commission, Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Fatigue Syndrome, Chronic; Fatigue
• Other Study ID Numbers: HKWC-2024-320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No