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

The University of Hong Kong (HKU)

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

Treatments: Drug: LingZhi capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06739720

HKWC-2024-320

Details and patient eligibility

About

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)

Enrollment: 130 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Drug: LingZhi capsule

Waitlist group

No Intervention group

Description:

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.