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

Phase 2

Not yet recruiting

• Conditions: Chronic Fatigue Syndrome (CFS); Post-COVID ME/CFS
• Interventions: Drug: LingZhi capsule

• Registration Number: NCT06739720
• Lead Sponsor: The University of Hong Kong

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-01-02
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	LingZhi capsule	Participants receive CP003 capsules (5 capsules once daily) for 6 weeks, followed by a 6-week follow-up period.

Primary Outcome Measures

Name	Time	Method
Mean difference in Chalder Fatigue Score	From baseline to 6 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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