The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19
CHM-Cov-19-RCT
1 other identifier
interventional
652
0 countries
N/A
Brief Summary
This is a prospective randomized controlled trial study to explore whether the combination of Chinese herbal medicine and Vitamin C is effective and safe to prevent COVID-19 transmission among health care workers in Hong Kong Mobile Cabin Hospital governed by the Hong Kong Hospital Authority who have been caring for patients with COVID-19. A total of 652 adults will be enrolled. Eligible subjects who provide written informed consent will be assessed for inclusion/exclusion criteria. All participants are asymptomatic and test negative for SARS-CoV-2 at the study's commencement. Subjects with major medical illness, renal insufficiency and hypersensitivity to Chinese herbal medicine will be excluded. All participants will receive Vitamin C (VC) supplementation and 28 packets of the herbal medicine free of charge and are advised to consume daily for 14 days. After written informed consent, the subjects will be included and randomly allocated to either CHM+VC group or VC treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started May 2022
Shorter than P25 for phase_2 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedMay 4, 2022
May 1, 2022
Same day
April 27, 2022
May 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who become SARS-CoV-2 positive
4 weeks
Secondary Outcomes (3)
Number of days of confirmed SARS-CoV-2 infection
4 weeks
Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
4 weeks
Safety endpoint
4 weeks
Study Arms (2)
CHM+Vc
EXPERIMENTALParticipants in CHM+VC group are required to consume vitamin C 1000mg/day and 1 sachet (9 g) of granules daily (1 hour after meal by dissolving 1 sachet of 9g granules in 150 ml of hot water and drink it orally) .
Vc
PLACEBO COMPARATORParticipants will receive vitamin C 1000mg/day for 14 days
Interventions
CHM is in the form of granules (9 g/sachet), which is comprised of 10 commonly used medicinal herbs: Codonopsis Radix, Astragali Radix, Lonicerae Japonicae Flos, Saposhnikovia Radix, Schizonepetae Herba, Mori Folium, Poria, Atractylodis Rhizoma, Atractylodis Macrocephala Rhizoma, Glycyrrhizae Radix et Rhizoma.
Eligibility Criteria
You may qualify if:
- Health care workers in Hong Kong Mobile Cabin Hospital;
- Asymptomatic and test negative for SARS-CoV-2;
- Aged ≥18;
- Voluntarily signing a written informed consent form;
You may not qualify if:
- With major medical illness or renal insufficiency;
- With hypersensitivity to Chinese herbal medicine;
- Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 27, 2022
First Posted
May 4, 2022
Study Start
May 1, 2022
Primary Completion
May 1, 2022
Study Completion
June 1, 2022
Last Updated
May 4, 2022
Record last verified: 2022-05