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NCT06054438Completed

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

Examining the Immunomodulatory and Health Improving Function of a Chinese Medicine Nutritional Supplement Cs4 on Immunity-related Disorders in the Post-COVID Era

Source: ClinicalTrials.gov · Last updated 9 Jul 2024

Brief summary (registry, in English)

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 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 treatment while group B will have no Cs4 treatment. In the second-stage clinical trial for 12 weeks, group A will have no Cs4 treatment while group B will have Cs4 treatment. A 12-week follow-up will be conducted after the intervention of Cs4 for group A. The primary outcome will be the change from 0 to 12 weeks in symptom severity measured by 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 change from 0 to 12 weeks 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). Blood tests will be assessed for safety study. primary outcomes and secondary outcomes will be assessed at baseline (week 0) and week 12. 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.

Status (registry)
Completed
Study type
Interventional
Enrollment
110 (actual)
First submitted
25 Sept 2023
Start date
17 Apr 2023
Primary completion date
31 Mar 2024
Lead sponsor
The University of Hong Kong
NCT number
NCT06054438

What you commit to

  • Study type: Interventional
  • Participants enrolled: 110
  • From 17 Apr 2023 to the primary completion date, 31 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis;
    • 4\. Pregnant or lactating women; 5. Impaired hepatic or renal function.

Other

  • Inability to read and/or write Chinese or English;

Who the study is looking for

  • Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
  • The self-declared post-COVID-19 Functional Status scale should be at least over 1;
  • The post-COVID symptoms have lasted at least 28 days after diagnosis;
  • Currently not taking any other orally administered Chinese medicine;
  • Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
  • Voluntary participation in this clinical study.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The School of Chinese Medicine, HKU
Coordinator of this site? Confirm its status
Hong KongChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.