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

NCT06054438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-07-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Chinese medicine nutritional supplement Cs4

Cs4 will be provided by Chinese Pharm, produced by GMP standard manufacturing. The intervention will be given according to the product instruction. Each capsule is 0.4g. According to the product sheet, adults should take 3-4 capsules daily as a way to nourish and strengthen the lungs and kidneys. In our study, the participants are people with long-COVID symptoms. Therefore, in order to achieve maximum efficacy, we will follow the directions and let participants take the maximum amount allowed by the product which is 4 capsules daily. Participants will take one capsule (each 400mg) 4 times a day, for a total of 1.6g. Treatment will last 12 weeks.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Yibin Feng, Doctor · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054438 on ClinicalTrials.gov