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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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kesuting syrup group | Experimental | Kesuting syrup, the tested drug of this study. |
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| LianHuaQingWen Granules Control group | Active Comparator | LianHuaQingWen Granules, referring to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9)", a NMPA approved drug for light and common patients with novel coronavirus during medical observation and clinical treatment,is adopted as active comparator in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kesuting syrup | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | up to 14 days |
| Cough disappearance time | Change from Baseline,record the time in hour it takes for the cough to go away . | Baseline, at cough disappears up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease recovery time | Evaluation of treatment endpoints | up to 14 days |
| Disease recovery rate | Evaluation of treatment endpoints | up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Ling | Shanghai Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 27, 2022 | |
| Reset | Aug 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 2022 | Aug 18, 2023 |
| ID | Term |
|---|---|
| D003371 | Cough |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| LianHuaQingWen Granules | Drug | 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. |
|
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| The time of negative conversion of new coronavirus. | Record the time of negative conversion of new coronavirus. | 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. | 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. | 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. | 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. | at baseline, 7 days of medication,up to 14 days |
| Incidence of severe/critical illness | Assess the incidence of severe/critical illness | up to 14 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |