Efficacy of Chinese Herbal Medicine to Prevent and Treat COVID-19 Close Contacts

NCT ID: NCT05269511

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2022-06-22

Brief Summary

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This is a randomized, blank-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection. All subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with SARS-CoV-2. Subjects in each cohort will be randomly assigned to the Chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment group

Chinese Herbal Medicine

Group Type EXPERIMENTAL

Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.

Intervention Type DRUG

Oral administration, twice per day.

Control group

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chinese herbal medicine is in the form of granules (9 g/sachet), which is comprised of ten medicinal herbs.

Oral administration, twice per day.

Intervention Type DRUG

Other Intervention Names

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Chinese herbal medicine

Eligibility Criteria

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Inclusion Criteria

1. Household contact exposure to individuals with SARS-CoV-2 infection
2. Aged ≥18
3. General healthy or have a chronic, stable medical condition
4. Voluntarily signing a written informed consent form
5. Able to follow written and oral instructions in Chinese

Exclusion Criteria

1. Moderate to severe symptomatic SARS-CoV-2 infection
2. An allergic history to Chinese herbal drugs or a known allergy to the ingredients of the study drug
3. Pregnancy, breastfeeding or plan to become pregnant within the study timeframe
4. Vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself)
5. Any physical examination findings, and/or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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ZhaoXiang Bian

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiping Lyu

Role: STUDY_DIRECTOR

School of Chinese Medicine, Hong Kong Baptist University

Locations

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School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Site Status

Countries

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China

References

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Du P, Lam WC, Leung C, Li H, Lyu Z, Yuen CS, Cheung CH, Lam TF, Bian Z, Zhong L. Efficacy and safety of Chinese herbal medicine to prevent and treat COVID-19 household close contacts in Hong Kong: an open-label, randomized controlled trial. Front Immunol. 2024 May 10;15:1359331. doi: 10.3389/fimmu.2024.1359331. eCollection 2024.

Reference Type DERIVED
PMID: 38799438 (View on PubMed)

Other Identifiers

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CHM COVID-19

Identifier Type: -

Identifier Source: org_study_id

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