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Evaluation of the efficacy of Yinqiao Baiyi Decoction in treating mild patients with COVID-19

Registration number：

ITMCTR2200006746

Date of Last Refreshed on：

2022-11-04

Date of Registration：

2022-11-04

Registration Status：

Prospective registration

Public title：

Evaluation of the efficacy of Yinqiao Baiyi Decoction in treating mild patients with COVID-19

English Acronym：

Scientific title：

Evaluation of the efficacy of Yinqiao Baiyi Decoction in treating mild patients with COVID-19

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065467 ; ChiMCTR2200006746

Applicant：

Zhao Hulei

Study leader：

Li Suyun

Applicant telephone：

18203661313

Study leader's telephone：

0371-66248624

Applicant Fax：

Study leader's fax：

Applicant E-mail：

hulei890421@163.com

Study leader's E-mail：

lisuyun2000@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

19 Renmin Road, Jinshui District, Zhengzhou, Henan,China

Study leader's address：

19 Renmin Road, Jinshui District, Zhengzhou, Henan,China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital to Henan University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022HL-433

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine

Date of approved by ethic committee：

2022/11/2 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

The First Affiliated Hospital to Henan University of Chinese Medicine

Primary sponsor's address：

19 Renmin Road, Jinshui District, Zhengzhou, Henan,China

Secondary sponsor：

Country：

China

Province：

Henan

City：

Institution
hospital：

The First Affiliated Hospital to Henan University of Chinese Medicine

Address：

Source(s) of funding：

No

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

A single-center, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy and safety of traditional Chinese medicine in treating mild COVID-19 patients

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Patients with mild COVID-19; ② Age 18-80 years old; ③ Voluntarily accept treatment and sign informed consent.

Exclusion criteria：

① delirious, consciousness disorder, dementia, all kinds of mental patients; ② Pregnant and lactating women; ③ Patients with active pulmonary tuberculosis, pulmonary abscess and chronic respiratory failure; ④ Patients with tumor; ⑤ Patients with severe liver and kidney diseases; ⑥ patients with severe cardiovascular and cerebrovascular diseases; ⑦ those who are taking part in clinical trials of other drugs and are known to be allergic to the treatment drugs.

Study execute time：

From 2022-10-20

To      2023-10-20

Recruiting time：

From 2022-11-10

To      2023-11-10

Interventions：

125

Group：

experimental group

Sample size：

Intervention：

Symptomatic treatment of Western medicine + Yinqiao Baiyi decoction

Intervention code：

125

Group：

control group

Sample size：

Intervention：

Symptomatic treatment of Western medicine + Yinqiao Baiyi decoction placebo

Intervention code：

Total sample size ： 250

Countries of recruitment
and research settings：

Country：

China

Province：

Henen

City：

Institution/hospital：

cabin hospital

Level of the institution：

/

Outcomes：

Outcome：

Cumulative incidence of adverse events

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

rate to the normal/heavy

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Nucleic acid turning negative time

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Time/rate of the abatement of fever

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Nucleic acid conversion rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Time/rate of clinical symptom remission

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Secretions from the throat

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Subjects were randomly enrolled using a computer or a random scale

Blinding：

IPD sharing：

No

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

Chinese Clinical Trial Registry

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

Case Record Form, CRF

Data Managemen Committee：

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

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