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Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

S

Sheng-Teng Huang

Status and phase

Completed
Phase 1

Conditions

Coronavirus Disease 2019
Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Treatments

Combination Product: Kang Guan Recipe (Treat)
Combination Product: Kang Guan Recipe (Placebo)

Study type

Interventional

Funder types

Other

Identifiers

NCT06291883
CHUH112-REC2-008

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups, including a placebo group

Treat
Experimental group
Description:
four packets of concentrated powder per day.
Treatment:
Combination Product: Kang Guan Recipe (Treat)
Control
Placebo Comparator group
Description:
four packets of concentrated powder per day.
Treatment:
Combination Product: Kang Guan Recipe (Placebo)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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