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Examining the Function of Cs4 on Post-COVID-19 Disorders

Sponsored by The University of Hong Kong

About this trial

Last updated 2 years ago

Study ID

UW23-011

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

Cordyceps is a medicinal Chinese medicine. The benefits of cordyceps-related therapeutic action have been studied due to its anti-inflammation and immunomodulation features. Thus, Cordyceps may have efficacy against inflammation-related health problems in the post-COVID era. the Cs4 is a Chinese medicine nutritional supplement fermented by Cordyceps. This Project conducts a two-stage waitlist-controlled trial to examine the therapeutic effect of the Cs4 on long-COVID patients. 110 Patients will be recruited and divided into two groups. Each group contains 55 patients. In the first-stage clinical trial for 12 weeks, group A will have no treatment while group B will have Cs4 treatment. In the second-stage clinical trial for 12 weeks, group A will have Cs4 treatment while group B will have no treatment. A 12-week follow-up will be conducted after the intervention of Cs4. The primary outcome will be the self-declared modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm). In our study, we intend to analyse the efficacy of Cs4 on the improvement of long Covid symptoms by using a comprehensive measurement to cover most symptoms, and be condition-specific. The secondary outcomes will include the self-declared validated Post-COVID-19 Functional Status (PCFS) Scale, five health condition surveys and blood tests assessed at baseline, end of the intervention and the end of follow-up. Health condition surveys include the score of Insomnia Severity Index (ISI), Brief Fatigue Inventory Form, St. George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS), and the Short Form 12 (SF12). A certain number of items are measured by scoring on each of these scales. There will be a total score for each scale. The anticipated outcome of the study is to provide evidence of Cs4 in the improvement of long COVID symptoms. This project can serve to the development of a nutritional supplement for the management of post-COVID-related health problems.

What are the participation requirements?

Yes

Inclusion Criteria

1. Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;

2. The self-declared post-COVID-19 Functional Status scale should be at least over 1;

3. The post-COVID symptoms have lasted at least 28 days after diagnosis;

4. Currently not taking any other orally administered Chinese medicine;

5. Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;

6. Voluntary participation in this clinical study.

No

Exclusion Criteria

1. Inability to read and/or write Chinese or English;

2. Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis;

4. Pregnant or lactating women; 5. Impaired hepatic or renal function.

Locations

Location

Status

Recruiting