Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

NCT ID: NCT06291883

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2024-02-08

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.

Conditions

Coronavirus Disease 2019; Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Treat

four packets of concentrated powder per day.

Group Type: EXPERIMENTAL

Kang Guan Recipe (Treat)

Intervention Type: COMBINATION_PRODUCT

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.

Control

four packets of concentrated powder per day.

Group Type: PLACEBO_COMPARATOR

Kang Guan Recipe (Placebo)

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheng-Teng Huang

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Teng Huang

Attending physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sheng-Teng Huang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, North District, Taiwan

Countries

Taiwan

Other Identifiers

CHUH112-REC2-008

Identifier Type: -

Identifier Source: org_study_id