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

NCT06739720 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HKWC-2024-320
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Fatigue Syndrome (CFS); Post-COVID ME/CFS

Outcome Measures

Primary Outcomes (1)

• Mean difference in Chalder Fatigue Score

  From baseline to 6 weeks

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Change in serum markers

  From baseline to 6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: LingZhi capsule

Waitlist group

NO INTERVENTION

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.

Interventions

LingZhi capsule DRUG

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

Intervention group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Innovation and Technology Commission, Hong Kong: collaborator

Study Sites (1)

Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

TUNG LEONG FONG

CONTACT

+852 5660 4020; tlfong@hku.hk

Guang Chen

CONTACT

+852 3917 6515; gchen91@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

HK (1)