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Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06291883
Enrollment
26
Registered
2024-03-04
Start date
2023-02-09
Completion date
2024-02-08
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

COMBINATION_PRODUCTKang 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.

COMBINATION_PRODUCTKang 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.

Sponsors

Sheng-Teng Huang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum Infection rate of pseudocellsBefore 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026