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A randomized, open-label, positive drug parallel controlled clinical trial of Kesuting syrup in the treatment of COVID-19 (Light)

Registration number：

ITMCTR2200005986

Date of Last Refreshed on：

2022-05-09

Date of Registration：

2022-05-09

Registration Status：

Prospective registration

Public title：

A randomized, open-label, positive drug parallel controlled clinical trial of Kesuting syrup in the treatment of COVID-19 (Light)

English Acronym：

Scientific title：

A randomized, open-label, positive drug parallel controlled clinical trial of Kesuting syrup in the treatment of COVID-19 (Light)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200059724 ; ChiMCTR2200005986

Applicant：

Jinxin Xiao

Study leader：

Yun Ling

Applicant telephone：

13885383954

Study leader's telephone：

18121157875

Applicant Fax：

Study leader's fax：

Applicant E-mail：

cassie_xjx@126.com

Study leader's E-mail：

Yun.ling@vip.126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.212 Xihang Road, Xixiu District, Anshun, Guizhou, China

Study leader's address：

No.2901 Caolang Road, Jinshan District, Shanghai

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guizhou Bailing Group Pharmaceutical Co., Ltd.

Approved by ethic committee：

Approved No. of ethic committee：

公卫伦审【2022】2022-E050-02号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Shanghai Public Health Clinical Center Ethics Committee

Date of approved by ethic committee：

2022/4/26 0:00:00

Contact Name of the ethic committee：

Feng Liu

Contact Address of the ethic committee：

Room 313,Prevention and Control East Building, No. 2901, Caolang Road, Jinshan District, Shanghai

Contact phone of the ethic committee：

Contact email of the ethic committee：

lunliweiyuanhui2009@126.com

Primary sponsor：

Shanghai Public Health Clinical Center

Primary sponsor's address：

No.2901 Caolang Road, Jinshan District, Shanghai

Secondary sponsor：

Country：

China

Province：

Guizhou

City：

Institution
hospital：

Guizhou Bailing Group Pharmaceutical Co., Ltd.

Address：

No.212 Xihang Road, Xixiu District, Anshun, Guizhou, China

Source(s) of funding：

Self-financing

Target disease：

COVID-19

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

Preliminary evaluate the clinical efficacy and safety of Kesuting syrup in the treatment of COVID-19 (Light) .

Description for medicine or protocol of treatment in detail：

Inclusion criteria

（1）Persons with COVID-19 (Light) in accordance with the "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)" . （2）Subjects with cough score > 1. （3）Inpatients aged 18 ≤ age ≤ 75 years old, regardless of gender. （4）Subjects (including male subjects) who have no plans for pregnancy, sperm donation, or egg donation in the past six months, and who are willing to take effective contraceptive measures from the first dose to 3 months after the last dose. （5）Subjects fully understand the purpose, nature, content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form.

Exclusion criteria：

(1)Ordinary, severe, and critically ill patients with novel coronavirus pneumonia, or patients with novel coronavirus pneumonia requiring mechanical ventilation. (2)patients with asthma attack, suppurative tonsillitis, acute and chronic bronchitis, sinusitis, otitis media and other respiratory diseases that affect clinical trial evaluation; And chest CT confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis, obstructive pulmonary disease and other basic pulmonary diseases. (3)Patients with respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development. (4)According to the judgment of the investigator, past or current chronic or serious diseases may affect participation in the trial or the outcome of the study, including but not limited to gastrointestinal system, cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, lymphatic system Patients with diseases of the system, endocrine system, immune system, malignant tumor, severe malnutrition, nervous system and endocrine system,as well as those currently suffering from human immunodeficiency virus (HIV) infection, splenectomy, organ transplantation and other diseases that seriously affect the immune system. (5)Those who cannot cooperate in mental state, those who suffer from mental illness, cannot control themselves, and cannot express themselves clearly. (6)Patients with diabetes. (7)Patients with poorly controlled hypertension: low pressure ≥110 mmHg or high pressure ≥180 mmHg. (8)ALT and AST ≥ 1.5 times the upper limit of normal, and Scr > the upper limit of normal. (9)Those who have a history of specific allergies (such as asthma, measles, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods such as milk and pollen), or are allergic to the drug ingredients of Kesuting Syrup and Lianhua Qingwen Granules. (10)Those with a history of drug abuse or dependence within 6 months before randomization. (11)Those who have used any Chinese and Western medicines to relieve cough and reduce phlegm within 24 hours before randomization. (12)Pregnant and lactating female patients. (13)Patients who have participated in or are participating in clinical trials of other drugs within 3 months prior to screening. (14)Investigators deem others unsuitable to participate in this clinical trial.

Study execute time：

From 2022-04-25

To      2022-09-24

Recruiting time：

From 2022-05-08

To      2022-06-27

Interventions：

100

Group：

Kesuting syrup test group

Sample size：

Intervention：

conventional treatment + KeSuting syrup, take orally, 20 ml once, three times a day.

Intervention code：

100

Group：

LianHuaQingWen Granules control group

Sample size：

Intervention：

conventional treatment + LianHuaQingWen Granules, orally, 1 bag at a time, 3 times a day.

Intervention code：

Total sample size ： 200

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Shanghai Public Health Clinical Center

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Incidence of severe/critical illness.

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cough efficacy

Type：

Primary indicator

Measure time point of outcome：

Baseline, 7 days of medication, end of study

Measure method：

Outcome：

The time and rate of negative conversion of new coronavirus.

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

cough disappearance time

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Disease recovery time, recovery rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Efficacy of single symptoms (fever, fatigue, sore throat).

Type：

Secondary indicator

Measure time point of outcome：

Baseline, 7 days of medication, end of study

Measure method：

Collecting sample(s)
from participants：

Sample Name：

saliva

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

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)：

A block random method was used. The statisticians used the SAS 9.4 statistical software PROC PLAN process statement, given the number of seeds, and generated a random arrangement of the treatments (Kesuting syrup test group, Lianhua Qingwen granules control group) received by 200 subjects, that is, the serial&#

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, ChiCTR，http://www.chictr.org.cn/about.aspx

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

CRF

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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