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Kesuting Syrup in the Treatment of Corona Virus Disease 2019 (COVID-19)

Primary Purpose

COVID-19 Pneumonia, Cough

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Kesuting syrup
LianHuaQingWen Granules
Sponsored by
Guizhou Bailing Group Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Kesuting syrup, COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Alanine Aminotransterase(ALT)and Aspartate Aminotransferase(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.

Sites / Locations

  • Shanghai Public Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kesuting syrup group

LianHuaQingWen Granules Control group

Arm Description

Kesuting syrup, the tested drug of this study.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Cough disappearance time
Change from Baseline,record the time in hour it takes for the cough to go away .

Secondary Outcome Measures

Disease recovery time
Evaluation of treatment endpoints
Disease recovery rate
Evaluation of treatment endpoints
The time of negative conversion of new coronavirus.
Record the time of negative conversion of new coronavirus.
The rate of negative conversion of new coronavirus.
Record rate of negative conversion of new coronavirus.
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.
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.
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.
Incidence of severe/critical illness
Assess the incidence of severe/critical illness

Full Information

First Posted
April 28, 2022
Last Updated
September 16, 2022
Sponsor
Guizhou Bailing Group Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05366231
Brief Title
Kesuting Syrup in the Treatment of Corona Virus Disease 2019 (COVID-19)
Official Title
A Randomized, Open-label, Positive Drug Parallel Controlled Clinical Trial of Kesuting Syrup in the Treatment of COVID-19 (Light)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Bailing Group Pharmaceutical Co Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia, Cough
Keywords
Kesuting syrup, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kesuting syrup group
Arm Type
Experimental
Arm Description
Kesuting syrup, the tested drug of this study.
Arm Title
LianHuaQingWen Granules Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Kesuting syrup
Other Intervention Name(s)
Kesuting Tangjiang
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LianHuaQingWen Granules
Other Intervention Name(s)
Lianhua Qingwen Keli
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cough efficacy assessed by cough symptom scale(CSS)
Description
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
Title
Cough efficacy by cough symptom scale(CSS)
Description
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
Title
Cough efficacy by cough symptom scale(CSS)
Description
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
Title
Cough disappearance time
Description
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
Secondary Outcome Measure Information:
Title
Disease recovery time
Description
Evaluation of treatment endpoints
Time Frame
up to 14 days
Title
Disease recovery rate
Description
Evaluation of treatment endpoints
Time Frame
up to 14 days
Title
The time of negative conversion of new coronavirus.
Description
Record the time of negative conversion of new coronavirus.
Time Frame
at baseline, 7 days of medication, up to 14 days
Title
The rate of negative conversion of new coronavirus.
Description
Record rate of negative conversion of new coronavirus.
Time Frame
at baseline, 7 days of medication, up to 14 days
Title
Efficacy of fever assessed by the single symptom grading standard formulated
Description
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
Title
Efficacy of fatigue assessed by the single symptom grading standard formulated
Description
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
Title
Efficacy of sore throat assessed by the single symptom grading standard formulated
Description
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
Title
Incidence of severe/critical illness
Description
Assess the incidence of severe/critical illness
Time Frame
up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persons with COVID-19 (Light) in accordance with the "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)" . Subjects with cough score > 1. Inpatients aged 18 ≤ age ≤ 75 years old, regardless of gender. 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. Subjects fully understand the purpose, nature, content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form. Exclusion Criteria: Ordinary, severe, and critically ill patients with novel coronavirus pneumonia, or patients with novel coronavirus pneumonia requiring mechanical ventilation. 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. 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. 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. Those who cannot cooperate in mental state, those who suffer from mental illness, cannot control themselves, and cannot express themselves clearly. Patients with diabetes. Patients with poorly controlled hypertension: low pressure ≥110 mmHg or high pressure ≥180 mmHg. Alanine Aminotransterase(ALT)and Aspartate Aminotransferase(AST) ≥ 1.5 times the upper limit of normal, and Scr > the upper limit of normal. 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. Those with a history of drug abuse or dependence within 6 months before randomization. Those who have used any Chinese and Western medicines to relieve cough and reduce phlegm within 24 hours before randomization. Pregnant and lactating female patients. Patients who have participated in or are participating in clinical trials of other drugs within 3 months prior to screening. Investigators deem others unsuitable to participate in this clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Ling
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kesuting Syrup in the Treatment of Corona Virus Disease 2019 (COVID-19)

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