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Effects of Fuzheng Huayu Tablets on COVID-19

NCT ID: NCT04645407

Last Updated: 2020-11-27

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

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-04-15

Brief Summary

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The 2019 novel coronavirus (2019-nCoV) infection caused clusters of severe respiratory illness similar to SARS and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected 2019-nCoV, most of them should receive supportive care to help relieve symptoms. This clinical trial is to evaluate the effect of Fuzheng Huayu tablet on lung inflammation in intensive patients with novel coronavirus pneumonia and reduce the progressive rate to critical type.

Detailed Description

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In December 2019, new coronavirus pneumonia (NCP) occurred in Wuhan, Hubei Province, which spread rapidly. Some of the patients developed into severe or critical illness. It became an international concerned public health emergencies and one of the major epidemics seriously endangering people's health and public safety after severe acute respiratory syndrome (SARS) in 2003.

At present, we lack the specific treatment for NCP. The anti- novel coronavirus drugs are been conducting in clinical trials, and the other options includes the symptomatic treatment. The pathological mechanism of the disease is not clear, but due to the continuous development of inflammation, some cases can become severe or critical, which threatening the life and health of patients. Intensive cases with obvious inflammation, after the control of acute symptoms and signs, often have the performance of pulmonary fibrosis, affecting the recovery of lung function. Therefore, actively reducing lung inflammation, controlling and reversing pulmonary fibrosis is of great significance for the life and health of patients Infected novel coronavirus.

Our previous study found that Fuzheng Huayu prescription can reduce the inflammation and fibrosis of the lung in the model rats, and improve the lung function of the patients with COPD. Therefore, we hope to take Fuzheng Huayu tablet to NCP patients, and observe whether it can reduce the lung inflammation of patients, so as to reduce the rate of progression of critical illness.

Conditions

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Novel Coronavirus Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FZHY Group

conventional therapy plus Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time.)

Group Type EXPERIMENTAL

Fuzheng Huayu tablet

Intervention Type DRUG

Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)

Control Group

conventional therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fuzheng Huayu tablet

Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients were included if they (1) had COVID-19; (2) were 18 to 65 years old; (3) did not participate in other drug clinical studies within 1 month before enrollment; and (4) voluntarily accepted treatment and signed an informed consent form.

Exclusion Criteria

Patients were excluded if they (1) had critical COVID-19; (2) were unconsciousness, had dementia, had psychiatric conditions, or were unable to communicate normally; (3) had severe cardiac insufficiency (i.e., cardiac function grade IV), severe liver or kidney disease, bronchial asthma, COPD, neurological disease, tumor, thoracic deformity, or immunodeficiency disease; (4) were pregnant or lactating or had a recent pregnancy plan; and (5) had a known allergy to any treatment drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Jingmen No.1 People's Hospital

OTHER

Sponsor Role collaborator

ShuGuang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Chenghai

Institute Director;PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shuguang Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Fzhy-ncp-1

Identifier Type: -

Identifier Source: org_study_id