Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Effectiveness and Safety of Jinhua Qinggan Granules (JHQG) for the Treatment of COVID 19 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 2
- 主要终点
- Change in Primary symptom (cough)
研究概览
简要总结
The clinical trial is designed to be randomized, double blind, placebo controlled, to evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day comprehensive follow-up. The informed consent form must be signed by the subjects before their participation in the trial.
详细描述
The course of treatment is 10 days, and the visit points are set on the 1st and 10th day, in which 10th day is follow-up. Patients will be assessed by using seven-category ordinal scale and clinical signs and symptoms on 1st and 10th day. If the subject recovers and checks out within 10 days, they will be recorded once before checking out. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 10th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable.
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
- Double (Participant, Care Provider)
盲法说明
Double blind
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
- •Between the ages of 18-75 years, both male and female.
- •Confirmed Coronavirus infection by real time RT-PCR.
- •Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned in 7.1.6).
- •The subject has signed the informed consent form;
排除标准
- •Younger than 18 years or older than 75 years.
- •Patients with moderate or critical Coronavirus infection confirmed by real time RT-PCR; cases meeting any of the following criteria:
- •Lung lesions
- •Respiratory failure and requiring mechanical ventilation
- •With other organ failure that requires ICU cares.
- •Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system (above grade II of cardiac function; ALT & AST are 1.5 times higher than the normal value; Creatinine above the upper limit of normal value) and mental illness or serious diseases affecting their survival, such as cancer or AIDS;
- •With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency.
- •Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit (including β2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.)
- •Allergic individuals and those who are known to be allergic to experimental drugs
- •Pregnant women, lactating women or fertile women who are ready to conceive in 3 months.
- •Subject, who has participated in the past 1 month in another clinical study.
- •Subjects who are not suitable for the clinical trial based on investigators' judgment.
结局指标
主要结局
Change in Primary symptom (cough)
时间窗: 10th day of treatment.
A grading symptom from 0-6 will be used to assess the symptom (Cough) where the score will be 0 for No cough, 2 for Intermittent cough, 4 for Cough mildly impacting the daily work and 6 Frequent cough or paroxysmal cough seriously impacting the work and life.
Change in Primary symptom (Fever)
时间窗: 10th day of treatment
A grading symptom from 0-6 will be used to assess the improvement of main clinical symptom (Fever) where the score will be 0 for No fever ≤ 37 °C (98.6°F), 2 for body temperature \> 37°C (98.6°F) to ≤ 38°C (100.4°F), 4 for body temperature \> 38°C (100.4°F) to ≤ 39°C (102.2°F) and 6 for body temperature \> 39°C (102.2°F) to ≤ 40°C (104°F).
Time for Negative COVID-19 Test
时间窗: 2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day
time for Negative coronavirus (COVID-19) Test on RT-PCR
次要结局
- Body temperature(10 days)
- white blood cells count(during the 10-day course of treatment)
- C-reactive protein test(during the 10-day course of treatment)
- ferritin test(during the 10-day course of treatment)
- Radiology(during the 10-day course of treatment)
- Quality of life assessment:(during the 10-day course of treatment)
研究者
Dr. Muhammad Raza Shah
Professor
University of Karachi