Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Serum Infection rate of pseudocells
研究概览
简要总结
These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.
详细描述
The ongoing coronavirus disease 2019 (COVID-19) pandemic continues to present challenges despite widespread vaccination efforts, with breakthrough infections remaining a concern. This has led to increased interest in exploring alternative preventive measures, including dietary and natural product-based interventions. Previous studies have demonstrated the potential of herbal medicines in inhibiting viral infections and as therapies for COVID-19. Additionally, research has identified various herbal medicines with inhibitory properties against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, highlighting their potential in combating the virus. Here Researchers found that novel herbal medicine formula Kang Guan Recipe (KGR) is a potent inhibitor against SARS-CoV-2 viral infection. Researchers demonstrated that KGR showed inhibitory activity against variants of concern (VOCs) of SARS-CoV-2 infection. Moreover, they also found that KGR can block the interaction of viral Spike and human angiotensin-converting enzyme 2 (ACE2). Furthermore, Researchers assessed the inhibitory effect of KGR on SARS-CoV-2 viral entry in vivo and observed that serum samples from healthy human subjects exhibited suppressive activity against various SARS-CoV-2 variants after consuming KGR. These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged 20-60 with a body weight of over 50 kilograms.
- •Individuals who have never been diagnosed with COVID-19 or have recovered from COVID-19 for more than three months.
- •No consumption of any traditional Chinese medicine or food containing Chinese medicine within the preceding 36 hours before the experiment.
- •Vaccinated individuals who received their vaccine more than three months ago.
- •Willingness to undergo venous blood tests (approximately 10 cc of blood to be drawn three times).
排除标准
- •History of major internal medical conditions, including diabetes, hypertension, chronic obstructive pulmonary disease (COPD), asthma, abnormal liver function (AST levels exceeding 5 times the normal value), renal dysfunction (eGFR <60), cancer, etc.
- •Brain disorders such as trauma, stroke, tumors, epilepsy, or dementia.
- •Mental health disorders such as depression, anorexia nervosa, or schizophrenia.
- •Pregnant or lactating women. If there is suspicion of pregnancy, a commercial urine pregnancy test will be conducted.
- •Smokers, alcoholics, or betel nut addicts.
- •Inability to comply with the trial procedures.
- •Inability to sign the informed consent form.
- •Within three months of a confirmed COVID-19 diagnosis.
- •Within three months of receiving a vaccine shot.
结局指标
主要结局
Serum Infection rate of pseudocells
时间窗: Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.
Collected Blood, centrifuge to obtain serum samples. Each serum sample were diluted and premixed with wild-type or different variants of SARS-CoV-2 spike Vpps for one hours before incubation with 293T-ACE2 cells. After 24 hours of infection, the infection efficiency rate was measured according to luciferase activities.
次要结局
未报告次要终点
研究者
Sheng-Teng Huang
Attending physician
China Medical University Hospital