Clinical trial NCT06291883: Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.
Official title: Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronavirus Disease 2019
Severe Acute Respiratory Syndrome Coronavirus 2 Infection
Keywords: coronavirus disease 2019
severe acute respiratory syndrome coronavirus 2
Kang Guan Recipe
variants of concern
angiotensin-converting enzyme 2
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum Infection rate of pseudocells
timeFrame: Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
affiliation: China Medical University Hospital
name: Sheng-Teng Huang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: