This trial is an exploratory study, aiming to explore the preliminary efficacy and safety of Kesuting Syrup in the treatment of novel coronavirus pneumonia. It is planned to include a total of 200 cases. Kesuting Syrup test group: Lianhua Qingwen Granules control group = 1:1, each 100 cases in each group.
This trial is a randomized, open-label, parallel-controlled clinical trial of active drugs.With reference to"Diagnosis and Treatment Protocol for COVID-19(Trial Version 9)", Lianhua Qingwen Granules have been recommended for mild and common patients during the medical observation period and clinical treatment period of the new coronavirus. The purpose of the experiment is preliminary evaluate the clinical efficacy and safety of Kesuting syrup in the treatment of COVID-19 (Light) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Conventional treatment + Kesuting Syrup, take orally, 20 ml once, three times a day.Conventional treatment refer to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)". Except for the test drugs, during the observation period, it is prohibited to use other Chinese and Western medicines for cough and phlegm elimination for treatment. If combined use is required, it shall be recorded truthfully.
Conventional treatment + LianHuaQingWen Granules, orally, 1 bag at a time, 3 times a day.Conventional treatment refer to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)".Except for the test drugs, during the observation period, it is prohibited to use other Chinese and Western medicines for cough and phlegm elimination for treatment. If combined use is required, it shall be recorded truthfully.
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Cough efficacy assessed by cough symptom scale(CSS)
Recording and evaluation of cough symptom scores by CSS(evaluation standards on the basis of the diagnosis and treatment of coughing guide (2015)),included daytime and nighttime cough symptom assessments,0 for normal, 1 for mild, 2 for moderate and 3 for severe,scores added.
Time frame: at baseline
Cough efficacy by cough symptom scale(CSS)
Recording and evaluation of cough symptom scores by CSS(evaluation standards on the basis of the diagnosis and treatment of coughing guide (2015)),included daytime and nighttime cough symptom assessments,0 for normal, 1 for mild, 2 for moderate and 3 for severe,scores added.
Time frame: at 7 days of medication
Cough efficacy by cough symptom scale(CSS)
Recording and evaluation of cough symptom scores by CSS(evaluation standards on the basis of the diagnosis and treatment of coughing guide (2015)),included daytime and nighttime cough symptom assessments,0 for normal, 1 for mild, 2 for moderate and 3 for severe,scores added.
Time frame: up to 14 days
Cough disappearance time
Change from Baseline,record the time in hour it takes for the cough to go away .
Time frame: Baseline, at cough disappears up to 14 days
Disease recovery time
Evaluation of treatment endpoints
Time frame: up to 14 days
Disease recovery rate
Evaluation of treatment endpoints
Time frame: up to 14 days
The time of negative conversion of new coronavirus.
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Record the time of negative conversion of new coronavirus.
Time frame: at baseline, 7 days of medication, up to 14 days
The rate of negative conversion of new coronavirus.
Record rate of negative conversion of new coronavirus.
Time frame: at baseline, 7 days of medication, up to 14 days
Efficacy of fever assessed by the single symptom grading standard formulated
Change from baseline individual symptoms (fever)markedly effective, effective or ineffective)at 7 days of medication and end of treatment,up to 14 days,according to the single symptom grading standard formulated.
Time frame: at baseline, 7 days of medication,up to 14 days
Efficacy of fatigue assessed by the single symptom grading standard formulated
Change from baseline individual symptoms (fatigue)markedly effective, effective or ineffective)at 7 days of medication and end of treatment,up to 14 days,according to the single symptom grading standard formulated.
Time frame: at baseline, 7 days of medication,up to 14 days
Efficacy of sore throat assessed by the single symptom grading standard formulated
Change from baseline individual symptoms ( sore throat)markedly effective, effective or ineffective)at 7 days of medication and end of treatment,up to 14 days,according to the single symptom grading standard formulated.
Time frame: at baseline, 7 days of medication,up to 14 days
Incidence of severe/critical illness
Assess the incidence of severe/critical illness
Time frame: up to 14 days