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NCT Number: NCT06739720

RCT of Efficacy and Safety of CP003 on CFS/ME or 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)

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Key information

Conditions

Chronic Fatigue Syndrome (CFS) Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-COVID ME/CFS

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Hong Kong

Location contact

TUNG LEONG FONG

CONTACT

[email protected]

+852 5660 4020

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Mean difference in Chalder Fatigue Score

    Time frame: From baseline to 6 weeks

Secondary outcomes

  1. Mean difference in Chalder Fatigue Score

    Time frame: From baseline to 12 weeks

  2. Mean difference in 36-Item Short-Form Health Survey

    Time frame: from baseline to 6 week and 12 week

  3. Mean difference in Fatigue Severity Score

    Time frame: from baseline to 6 week and 12 week

  4. mean difference in (PROMIS) Short Form Fatigue 7A survey

    Time frame: from baseline to 6 week and 12 week

  5. Mean difference in hospital anxiety and depression scale

    Time frame: from baseline to 6 week and 12 week

  6. Mean difference in Pittsburgh sleep quality index

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

Other outcomes

  1. Change in serum markers

    Time frame: From baseline to 6 weeks

    for inflammation, immunity and oxidative aging

Study contacts

Contact information is provided by the study sponsor or research team.

Guang Chen

CONTACT

[email protected]

+852 3917 6515

TUNG LEONG FONG

CONTACT

[email protected]

+852 5660 4020

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Innovation and Technology Commission, Hong Kong

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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