A Randomized, Open-label, Positive Drug Parallel Controlled Clinical Trial of Kesuting Syrup in the Treatment of COVID-19 (Light)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cough disappearance time
研究概览
简要总结
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.
详细描述
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) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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.
排除标准
- •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.
研究组 & 干预措施
Kesuting syrup group
Kesuting syrup, the tested drug of this study.
干预措施: Kesuting syrup (Drug)
LianHuaQingWen Granules Control group
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.
干预措施: LianHuaQingWen Granules (Drug)
结局指标
主要结局
Cough disappearance time
时间窗: Baseline, at cough disappears up to 14 days
Change from Baseline，record the time in hour it takes for the cough to go away .
Cough efficacy assessed by cough symptom scale（CSS）
时间窗: at baseline
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）
时间窗: up to 14 days
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.
次要结局
- Efficacy of sore throat assessed by the single symptom grading standard formulated(at baseline, 7 days of medication,up to 14 days)
- Disease recovery time(up to 14 days)
- Efficacy of fever assessed by 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(at baseline, 7 days of medication,up to 14 days)
- The time of negative conversion of new coronavirus.(at baseline, 7 days of medication, up to 14 days)
- Incidence of severe/critical illness(up to 14 days)
- The rate of negative conversion of new coronavirus.(at baseline, 7 days of medication, up to 14 days)
- Disease recovery rate(up to 14 days)