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A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19

NCT ID: NCT04433013

Last Updated: 2021-11-23

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

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-02-28

Brief Summary

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COVID-19 virus remains in infected patients for extended periods of time. A great resource burden is placed on the healthcare system and society at large to isolate COVID-19 patients for prolonged periods. Thus, being able to increase the rate of viral clearance, thus reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to free up resources for those who require it. The investigators designed a randomized controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19 infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days of TCM treatment when compared to the group of patients provided with standard care and placebo. Patients will be recruited from community isolation facilities, and have onset of symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates the time taken for relief of clinical symptoms associated with COVID-19 and assesses the safety of the TCM treatment given to patients.

Detailed Description

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Conditions

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COVID-19

Keywords

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COVID-19 Traditional Chinese Medicine Randomized Controlled Trial Lianhua Qingwen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Lianhua Qingwen

Intervention Type DRUG

The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Interventions

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Lianhua Qingwen

The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Intervention Type DRUG

Placebo

The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥21 years
2. Positive laboratory test for COVID-19 by RT-PCR methods
3. Presenting with at least one symptom (symptoms include fever, dry cough, sore throat, nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
4. Length of time between date of onset of symptoms and the date of recruitment should not exceed 5 days to ensure that trial participants are in the early stages of infection
5. No clinical or radiographic evidence of pneumonia
6. Able to provide informed consent

Exclusion Criteria

1. Individuals with underlying primary diseases such as cardiovascular, respiratory, liver, renal, diabetes, hepatitis A/B/C, gout or endocrinological diseases and neurological disorders which put them at a higher risk of developing severe disease
2. Individuals with compromised immune systems such as malignant tumors, organ or bone marrow transplants, HIV, or have taken immunosuppressants in the past three months.
3. Women who are pregnant or on lactation.
4. Individuals with mental illness.
5. History of allergy to any drug or food, or herb ingredient observed in this trial.
6. Individuals who are deemed not able to comply with trial procedure or follow-up
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Singapore

OTHER_GOV

Sponsor Role collaborator

Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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Zhao Yan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Zhao

Role: PRINCIPAL_INVESTIGATOR

Nanyang Technological University

Other Identifiers

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IRB-2020-05-029

Identifier Type: -

Identifier Source: org_study_id