Coronavirus Disease 2019Phase 1NCT06291883
Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.
A Phase 1 study testing Kang Guan Recipe (Treat) in people with Coronavirus Disease 2019 and Severe Acute Respiratory Syndrome Coronavirus 2 Infection, run by Sheng-Teng Huang at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019, Severe Acute Respiratory Syndrome Coronavirus 2 Infection
- What is being tested?
- Kang Guan Recipe (Treat)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Feb 2023to 8 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.
Read the 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.
- Being tested
- Kang Guan Recipe (Treat), Kang Guan Recipe (Placebo)
- Keywords
- coronavirus disease 2019, severe acute respiratory syndrome coronavirus 2, Kang Guan Recipe, variants of concern, angiotensin-converting enzyme 2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kang Guan Recipe (Treat)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.
Kang Guan Recipe (Placebo)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.
| Study group | Role | What they receive |
|---|---|---|
| Treat | Experimental | four packets of concentrated powder per day. Receives: Combination Product: Kang Guan Recipe (Treat) |
| Control | Placebo comparator | four packets of concentrated powder per day. Receives: Combination Product: Kang Guan Recipe (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start9 Feb 2023
- Primary completion18 Apr 2023
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheng-Teng Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng-Teng Huang, China Medical University Hospital
- Investigators
- Sheng-Teng Huang, MD PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291883
- Sponsor's protocol ID
- CHUH112-REC2-008
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.
- ClinicalTrials.gov ID
- NCT06291883
- Acronym / sponsor ID
- CHUH112-REC2-008
- Keywords
- coronavirus disease 2019, severe acute respiratory syndrome coronavirus 2, Kang Guan Recipe, variants of concern, angiotensin-converting enzyme 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sheng-Teng HuangUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treat | Experimental | Combination Product: Kang Guan Recipe (Treat)four packets of concentrated powder per day. |
| Control | Placebo comparator | Combination Product: Kang Guan Recipe (Placebo)four packets of concentrated powder per day. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Treat |
| 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. | Combination product | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Teng Huang, MD PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kang Guan Recipe (Treat) in people with Coronavirus Disease 2019 and Severe Acute Respiratory Syndrome Coronavirus 2 Infection, run by Sheng-Teng Huang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Infection rate of pseudocells (time frame: Before taking, 2 hours after taking, and 2 hours after taking 24 hours later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.