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A prospective, real-world cohort study of Huashi Baidu granule in the treatment of mild or asymptomatic COVID-19

Registration number：

ITMCTR2200005856

Date of Last Refreshed on：

2022-04-13

Date of Registration：

2022-04-13

Registration Status：

Prospective registration

Public title：

A prospective, real-world cohort study of Huashi Baidu granule in the treatment of mild or asymptomatic COVID-19

English Acronym：

Scientific title：

A prospective, real-world cohort study of Huashi Baidu granule in the treatment of mild or asymptomatic COVID-19

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200058668 ; ChiMCTR2200005856

Applicant：

yuanweian

Study leader：

gaoyueqiu

Applicant telephone：

021-20256051

Study leader's telephone：

021-20256051

Applicant Fax：

Study leader's fax：

Applicant E-mail：

weian_1980@163.com

Study leader's E-mail：

gaoyueqiu@hotmail.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 528, zhangheng Road, Pudong New Area, Shanghai

Study leader's address：

No. 528, zhangheng Road, Pudong New Area, Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022-1097-34-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of Shuguang Hospital affiliated with Shanghai University of TCM

Date of approved by ethic committee：

2022/3/30 0:00:00

Contact Name of the ethic committee：

Geng Xi

Contact Address of the ethic committee：

No. 528, zhangheng Road, Pudong New Area, Shanghai

Contact phone of the ethic committee：

021-20256070

Contact email of the ethic committee：

sgyyllwyh@126.com

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Primary sponsor's address：

No. 528, zhangheng Road, Pudong New Area, Shanghai

Secondary sponsor：

Country：

CHINA

Province：

SHANGHAI

City：

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Address：

No. 528, zhangheng Road, Pudong New Area, Shanghai

Source(s) of funding：

Shanghai Municipal Health Commission

Target disease：

covid-19

Target disease code：

Study type：

Interventional study

Study design：

Cohort study

Study phase：

Phase I clinical trial

Objectives of Study：

To evaluate the efficacy and safety of Huashi Baidu granule in treating mild or asymptomatic infections in COVID-19

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Age 18-60 years old (including 18 and 60 years old), regardless of gender; (2) nucleic acid test results were positive, including New Coronavirus mild / asymptomatic infection. (3) Voluntarily participate in the experiment and sign the written informed consent.

Exclusion criteria：

(1) Complicated with influenza, other pneumonia, suppurative tonsillitis, acute tracheobronchial inflammation, pulmonary tuberculosis, primary ciliary dyskinesia syndrome, and other acute nasal diseases (such as allergic rhinitis, acute and chronic rhinitis, acute and chronic sinusitis, etc.); (2) During the course of the disease, he has received other oral drugs for the disease before treatment, such as cold drugs, antiviral drugs, antibiotics, traditional Chinese medicine and other drugs; (3) Accompanied by gastrointestinal discomfort symptoms such as acute and chronic diarrhea; (4) merge serious serious diseases such as heart, brain, lung, liver, kidney and blood system, such as viral hepatitis, hemophilia, diabetes mellitus, mental illness, etc. (5) Pregnant or planned pregnant women, lactating women, patients of childbearing age who are unable or unwilling to take adequate contraception during the trial, or their spouses are unwilling to take contraception; (6) Allergic constitution, such as a history of allergy to more than two drugs or foods, or known allergy to various components of the drug in this study; (7) Participate in or are participating in clinical trials of other drugs within 3 months; (8) Those who are unwilling to accept the intervention of traditional Chinese medicine; (9) According to the judgment of the researcher, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as pregnancy, frequent changes in working environment, unstable living environment and other conditions that are easy to cause loss of follow-up.

Study execute time：

From 2022-04-20

To      2022-06-30

Recruiting time：

From 2022-04-20

To      2022-05-31

Interventions：

500

Group：

control group

Sample size：

Intervention：

conventional therapy

Intervention code：

500

Group：

Test group

Sample size：

Intervention：

Huashi Baidu granule

Intervention code：

Total sample size ： 1000

Countries of recruitment
and research settings：

Country：

CHINA

Province：

SAHNGHAI

City：

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Level of the institution：

Class A tertiary hospita

Outcomes：

Outcome：

Conversion rate within 6 days: the percentage of mild / asymptomatic patients progressing to normal within 6 days

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Mean time of negative conversion: from the first positive report of New Coronavirus nucleic acid test in Shanghai to the two negative interval of more than 24 hours interval in CDC.

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Average hospital stay: the average time of patients from entry to exit

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Clinical symptom efficacy: refers to the disappearance rate and improvement rate of clinical symptoms before and after treatment.

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Nucleic acid negative conversion rate: the percentage of nucleic acid negative conversion of patients' nasopharyngeal swab at an interval of more than 24 hours

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

/

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

18
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Cohort studies do not require randomization.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

De identified database

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic Data Capture, EDC

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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