Examining the immunomodulatory and health improving function of a Chinese medicine nutritional supplement Cs4 on immunity-related disorders in the post-COVID era

Professor Feng, Yibin   (Principal Investigator (PI))

24

2023-06-01

450137

Examining the immunomodulatory and health improving function of a Chinese medicine nutritional supplement Cs4 on immunity-related disorders in the post-COVID era

immunomodulatory, health improving function, Chinese medicine nutritional supplement Cs4, immunity-related disorders, post-COVID

Chinese Medicine (clinical)

PRP/069/22FX

Partnership Research Programme (PRP) - 2022

2023

On-going

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) , an ordinal patient-reported outcome measure, reported via WhatsApp every 4 week during 12-weeks intervention and 12-week follow up. C19-YRSm is the first validated scale describing post‐COVID‐19 symptoms and grading the severity of symptoms and functional disability. The C19-YRS has four subscales concerned with the severity of patients' symptoms, functional ability, additional symptoms, and overall health. The scale has been recommended in NHS England Clinical Guidance for PCS services and NICE rapid guidelines. 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. Efficacy index will be calculated to evaluate the efficacy in improving symptoms by using the formulas: efficacy index (EI) = (total score at baseline – total score after treatment) / total score at baseline * 100%. Positive Efficacy index indicates improved condition for the patients. 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.