Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

March 4, 2024 updated by: Sheng-Teng Huang
These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • North District
      • Taichung, North District, Taiwan, 404
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treat
four packets of concentrated powder per day.
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.
Placebo Comparator: Control
four packets of concentrated powder per day.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Infection rate of pseudocells
Time Frame: Before 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.
Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheng-Teng Huang

Investigators

  • Principal Investigator: Sheng-Teng Huang, MD PhD, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUH112-REC2-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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