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

Hong Kong Baptist University

Status and phase: Unknown; Phase 2

Conditions: COVID-19

Treatments: Drug: Chinese herbal medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05360004

REC/21-22/0458

Details and patient eligibility

About

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.

Enrollment: 652 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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652 participants in 2 patient groups, including a placebo group

CHM+Vc

Experimental group

Description:

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) .

Treatment:

Drug: Chinese herbal medicine

Vc

Placebo Comparator group

Description:

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

Treatment:

Drug: Chinese herbal medicine