Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

Coronavirus Disease 2019 Clinical Trial

Official title:

Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06291883
• Other study ID #: CHUH112-REC2-008
• Status: Completed
• Phase: Phase 1
• Start date: February 9, 2023
• Est. completion date: February 8, 2024

Study information

• Verified date: March 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 8, 2024
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19
• Infections
• Severe Acute Respiratory Syndrome

Intervention

Combination Product:
• Kang Guan Recipe (Treat)
Accurately weigh the Chinese medicinal herbs in the formula by weight, conduct the origin identification of the medicinal materials, and follow the scientific traditional Chinese medicine preparation process. After extraction, concentration, and granulation, package them in aluminum foil, with each package containing 6 grams of concentrated powder.
• Kang Guan Recipe (Placebo)
Use 3% Kang Guan Recipe concentrated powder, mix evenly with starch, and package in aluminum foil, with each package containing 6 grams of concentrated powder.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	North District

Sponsors (1)

Lead Sponsor	Collaborator
Sheng-Teng Huang

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Infection rate of pseudocells	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.	Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.