Efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang With Ginseng) on Mild and Moderate COVID-19 Patients: A Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The time required to meet discharge standards
研究概览
简要总结
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes COVID-19 (coronavirus disease 2019). Patients with COVID-19 may experience various clinical manifestations, from no symptoms to critical illness such as severe pneumonia and acute respiratory distress syndrome (ADRS). So far, there is no specific medication for COVID-19; hence, the current available treatments mostly aim at symptoms management and supportive care. From traditional medicine perspective, COVID-19 is classified as warm-disease (Wen-yi). The main points of treatment for COVID-19 in early stage based on traditional medicine perspective are strengthen the Protective Qi (Wei Qi - the body immune system), and restore the balance of Qi, which is vital biological energy to prevent the invasion of external pathogens, including the SARS-CoV-2 virus. The Shen Cao Gan Jiang Tang have including Gan Cao Gan Jiang Tang (GGT) with the addition of Ginseng. This formula is originated from Shang Han Lun (Treatise on Febrile Diseases Caused by Cold) by Zhang Zhong-jing, used to enhance the Protective Qi, treat the early stage of Febrile Diseases, This clinical trial aims to evaluate the efficacy of the Shen Cao Gan Jiang Tang on mild and moderate COVID-19 patients
详细描述
The main objectives of this clinical trial:
- Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing duration and severity of symptoms compared with the standard of care in mild and moderate COVID-19 patients.
- Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing the proportion of patients progressed to severe level compared with the standard of care in mild and moderate COVID-19 patients.
- Assess the efficacy of Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) in addition to the standard of care on reducing the time required to meet discharge standards compared with the standard of care in mild and moderate COVID-19 patients.
This study is investigated by the following hypotheses: combining Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) with the standard of care is effective in reducing the duration and severity of symptoms, reducing the proportion of patients progressed to severe level, and reducing the length of hospital stay on mild and moderate COVID-19 patients
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
- None
盲法说明
An open-label study was conducted because of the urgency of major public health events
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From full 18 to 64 years old;
- •The patient was diagnosed with SARS-CoV-2 infection by RT-PCR confirmation (+) and CT <
- •Patients classified as mild (acute upper respiratory tract infection): patients infected with SARS-CoV-2 early in the first 5 days from the time of having one of the non-specific clinical symptoms such as fever, cough dry, sore throat, stuffy nose, fatigue, headache, muscle pain, decreased taste, decreased sense of smell. And there are no signs of pneumonia or hypoxia, respiratory rate ≤ 20 times/min, Saturation of Peripheral Oxygen (SpO2) ≥ 96% when breathing air.
- •Patients classified as moderate (Pneumonia): patients infected with SARS-CoV-2 in the first 10 days from the time of having one of the non-specific clinical symptoms, showing signs of pneumonia (fever, cough, dyspnea, tachypnea >20 breaths/min) and no signs of severe pneumonia, Saturation of Peripheral Oxygen (SpO2) ≥ 93% when breathing air.
- •Inpatient treatment
- •Subjects do not use any other medicines with herbal ingredients for underlying conditions or any other purposes;
- •Voluntary participation in the study by signing an informed consent
- •Patients who have not been vaccinated or have just received 1 dose of COVID-19 vaccine
排除标准
- •Severe or critical COVID-19 based on the COVID-19 severity scale of Vietnam Ministry of Health;
- •Chronic obstructive pulmonary disease, kidney failure requiring dialysis or creatinine ≥ 2.0mg/dl through medical history; parenteral or parenteral nutrition, uncontrolled type 2 diabetes (HbA1c > 7%), uncontrolled hypertension (value > 160/100 mmHg), uncontrolled coronary artery disease (new/currently established) requires medication adjustment), heart failure, neurological disease (eg, acute stroke, polyneuritis within 1 month) or mental illness, active tuberculosis, active autoimmune disease;
- •Have a chronically weakened immune system (AIDS, cancer, undergoing chemotherapy-radiotherapy in the past six months, immunosuppressive disease);
- •Taking immunosuppressive drugs (e.g., anti-rejection treatment after organ transplant or blood stem cell transplant);
- •Allergic to products that contain ginseng;
- •Pregnant or lactating women;
- •Already participating in another clinical trial;
- •The patient has received 2 doses of COVID-19 vaccine.
研究组 & 干预措施
• Experimental: Investigational arm
Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) and the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline.
干预措施: Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng) (Drug)
结局指标
主要结局
The time required to meet discharge standards
时间窗: During inpatient treatment, maximum to Day 21 after randomization
Time (days) from randomization to get required for a negative real-time polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 or CT \> 30
Duration of symptoms of COVID-19
时间窗: From Day 1 to Day 21 after randomization
Time (days) from randomization to symptoms disappear
The severity of the COVID-19 total and individual symptoms
时间窗: From Day 1 to Day 21 after randomization
Time (days) from randomization to the relief of total and individual COVID-19 symptoms scores
Rate of progression to disease severity
时间窗: During inpatient treatment, maximum to Day 21 after randomization
Number of patients (%) progressed to severe level of COVID-19 severity scale based on the Vietnam Ministry of Health severity scale during the period of the treatment
National Early Warning Score 2 (NEWS2)
时间窗: During inpatient treatment, maximum to Day 21 after randomization
Assessed by National Early Warning Score 2 (NEWS2)
次要结局
- Number of participants clinically recovered(From Day 1 after randomisation to Day for patients meet discharge criteria)
- Duration of SARS-CoV-2 virus infection(During inpatient treatment, maximum to Day 21 after randomization)
- Mortality rate(From Day 1 to Day 21 after randomization)
- Paracetamol/Ibuprofen intake(From Day 1 after randomisation to Day for patients meet discharge criteria)
- Safety evaluation(From Day 1 to Day 21 after randomization)
- Cycle threshold (CT)(During inpatient treatment, maximum to Day 21 after randomization)
研究者
NGUYEN VAN DAN
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City