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Study on the efficacy of Xuanfeizhisou Mixture in the treatment of COVID-19 cough

Registration number：

ITMCTR2200006141

Date of Last Refreshed on：

2022-06-15

Date of Registration：

2022-06-15

Registration Status：

Prospective registration

Public title：

Study on the efficacy of Xuanfeizhisou Mixture in the treatment of COVID-19 cough

English Acronym：

Scientific title：

Study on the efficacy of Xuanfeizhisou Mixture in the treatment of COVID-19 cough

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200061070 ; ChiMCTR2200006141

Applicant：

Xuan Chen

Study leader：

Wei Zhang

Applicant telephone：

13611899735

Study leader's telephone：

13023153956

Applicant Fax：

Study leader's fax：

Applicant E-mail：

chen77xuan@aliyun.com

Study leader's E-mail：

zhangw1190a@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Shuguang Hospital, No. 528, Zhanghen Road, Shanghai, China

Study leader's address：

Shuguang Hospital, No. 528, Zhanghen Road, Shanghai, China

Applicant postcode：

201203

Study leader's postcode：

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University of T.C.M.

Approved by ethic committee：

Approved No. of ethic committee：

2022-1125-62-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of T.C.M.

Date of approved by ethic committee：

2022/5/18 0:00:00

Contact Name of the ethic committee：

Junjian Ma

Contact Address of the ethic committee：

Shuguang Hospital, No. 528, Zhanghen Road, Shanghai, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of T.C.M.

Primary sponsor's address：

Shuguang Hospital, No. 528, Zhanghen Road, Shanghai, China

Secondary sponsor：

Source(s) of funding：

Shuguang Hospital Affiliated to Shanghai University of T.C.M.

Target disease：

COVID-19

Target disease code：

Study type：

Interventional study

Study design：

Case-Control study

Study phase：

Pilot clinical trial

Objectives of Study：

To explore the efficacy and adverse reactions of Xuanfeizhisou mixture in the treatment of COVID-19 cough with T.C.M.(dampness and temperature invading lung syndrome) syndrome , and provide evidence for the clinical application.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Patients with mild and moderate novel coronavirus pneumonia confirmed in accordance with the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9th); (2) TCM syndrome differentiation is wind evil and lung syndrome; (3) Two points for cough symptoms score; (4) Age is over 18-75 years old, with no limit on gender.

Exclusion criteria：

(1) Patients with severe pneumonia requiring mechanical ventilation and critical novel coronavirus pneumonia; (2) Those who are expected to die within 48 hours; (3) Respiratory tract infections caused by primary immune deficiency disease, acquired immune deficiency syndrome, congenital respiratory malformations, congenital heart disease, lung development abnormalities and other basic diseases; (4) Chest CT confirmed the existence of serious lung interstitial lesions and other underlying lung diseases; (5) According by the researchers, previous or current diseases may affect the outcome of patient trials or research, including malignant diseases, autoimmune diseases, severe malnutrition, etc.; and diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc. (6) Women during pregnancy and lactation.

Study execute time：

From 2022-06-01

To      2023-06-01

Recruiting time：

From 2022-06-01

To      2023-06-01

Interventions：

120

Group：

treatment group

Sample size：

1

Intervention：

usual care+Xuanfeizhisou Mixture

Intervention code：

40

Group：

control group

Sample size：

2

Intervention：

usual care

Intervention code：

Total sample size ： 160

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of T.C.M.

Level of the institution：

tertiary

Outcomes：

Outcome：

cough disappear rate at the 7th day

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

time of cough diappear day

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM symdrome efficacy

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

cough index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

cough VAS score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

cough relieve time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

case control

Blinding：

IPD sharing：

No

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

no

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

no

Data Managemen Committee：

Yes

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

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