The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19

NCT ID: NCT05360004

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 652 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-06-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CHM+Vc

Participants 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) .

Group Type: EXPERIMENTAL

Chinese herbal medicine

Intervention Type: DRUG

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.

Vc

Participants will receive vitamin C 1000mg/day for 14 days

Group Type: PLACEBO_COMPARATOR

Chinese herbal medicine

Intervention Type: DRUG

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.

Interventions

Chinese herbal medicine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Health care workers in Hong Kong Mobile Cabin Hospital;

2. Asymptomatic and test negative for SARS-CoV-2;

3. Aged ≥18;

4. Voluntarily signing a written informed consent form;

Exclusion Criteria

1. With major medical illness or renal insufficiency;

2. With hypersensitivity to Chinese herbal medicine;

3. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

ZhaoXiang Bian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

REC/21-22/0458

Identifier Type: -

Identifier Source: org_study_id