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

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chinese herbal medicine
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Chinese herbal medicine, Prevention, Health Care Worker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CHM+Vc

    Vc

    Arm 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) .

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

    Outcomes

    Primary Outcome Measures

    Proportion of subjects who become SARS-CoV-2 positive

    Secondary Outcome Measures

    Number of days of confirmed SARS-CoV-2 infection
    Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
    Safety endpoint
    Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs (TEAEs are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition).

    Full Information

    First Posted
    April 27, 2022
    Last Updated
    May 3, 2022
    Sponsor
    Hong Kong Baptist University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05360004
    Brief Title
    The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19
    Acronym
    CHM-Cov-19-RCT
    Official Title
    The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in Hong Kong Mobile Cabin Hospital to Prevent COVID-19 Transmission: A Prospective, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    May 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hong Kong Baptist University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    Chinese herbal medicine, Prevention, Health Care Worker

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, open-labelled, controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    652 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CHM+Vc
    Arm Type
    Experimental
    Arm 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) .
    Arm Title
    Vc
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive vitamin C 1000mg/day for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Chinese herbal medicine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of subjects who become SARS-CoV-2 positive
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Number of days of confirmed SARS-CoV-2 infection
    Time Frame
    4 weeks
    Title
    Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
    Time Frame
    4 weeks
    Title
    Safety endpoint
    Description
    Proportion of subjects with treatment-emergent adverse events (TEAEs) and severity of TEAEs (TEAEs are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition).
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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; Exclusion Criteria: With major medical illness or renal insufficiency; With hypersensitivity to Chinese herbal medicine; Pregnancy or lactation.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    All participant data will be de-identified.

    Learn more about this trial

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

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