Clinical trial NCT04790240: Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID)
Official title: The Trial Uses Medicinal Herbs to Direct T Cells to Engulf the COVID-19 Virus and Protect the Organs Well
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Covid19 Virus Infection
Keywords: Medicinal Herbs
Virus
COVID-19
Coronavirus Disease 2019
Infections
Inflammation
Immunity
Metabolite
clots
thrombus
Viral Pneumonia
Fever
Cough
Chest congestion
Lead sponsor: All Natural Medicine Clinic, LLC
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are randomly divided into two groups: the treatment group and the control group. Both groups receive the same medications, but the treatment group also receives medical herbs to compare both groups' differences on their symptoms and blood data, virus marks.
Primary purpose: TREATMENT

Brief summary: The human immune system is designed to protect individuals from external sources of infection and internal cell mutation. It works effectively and efficiently until inflammation disturbs its functioning. Once compromised by inflammation, the immune system loses its capacity to recognize antigens and dependably defend the body against disease and illness.

When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back. When the medical herbs join the body, it can slow down the immune reaction. Medical herbs benefit the physical body; they protect the cells and organism structure and mediate the immune response, allowing the T cells to kill the virus (mutated or not) internally. Such success has been achieved by the All Natural Medicine Clinic during pre-clinical trials.

This clinical study's goal is to demonstrate that the immune system can be rebuilt and retrained, using natural medicine (i.e., medical herbs), to kill the virus without causing the immune storm, and to explore the mechanism by which these medical herbs, which have been used for thousands of years for healing, achieve results.

Detailed description: According to CDC data, as of January 30, 2021, 25,780,144 individuals residing in the United States had been infected by COVID-19 and 435,151 had died as a result of the disease. No drug has yet been identified that explicitly kills the COVID-19 virus. While various vaccines have been developed to prevent infection, the virus continues to mutate, and scientific research remains behind the virus trajectory.

The human immune system, when functioning properly, can prevent the body from succumbing to infections from external sources and from internal cell mutations, including the COVID-19 virus and cancer cells. That is, the defense system comes from nature. This clinical study proves that the immune system can respond to those antigens and kill them if the immune system is given a chance. However, the human immune system can become compromised through inflammation and subsequently unable to successfully prevent infection and cancer.

When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over-immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back.

Medical herbs can mediate the immunity disorder caused by infections, and mutated cells, including COVID-19 and its mutations. Our pre-clinical study found that the medical herbs inhibit the inflammation expression, reduce the chance of cytokine-storm, prevent deterioration, and reduce the mortality rate. In addition, the T cells can perform their job when the inflammation is under control. The virus and cancer cells belong to antigens that should be killed by natural killer (NK) cells and T cells. This clinical study aims not to provide drugs to kill the antigens, but rather to create the necessary conditions inside the human body to allow the immune system a chance to overcome the antigens. The clinic has used this treatment concept to successfully treat infected patients and cancer patients.

Eligibility criteria: Inclusion Criteria:

A subject will be eligible for inclusion in this study if any of the following criteria apply:

* Individuals diagnosed with COVID-19 virus infection in the past 1-20 days must submit the proved metrics of COVID-19 virus marks positive during the registration;
* The age of participants is between 10-70 years old;
* The participants are received or not received conventional medication treatment, and continuing the treatment patients, could be enrolled in this clinical study;
* This clinical study is not restricted to gender, age, sex, race, and nationality;
* The participants must have reports of CBC, C3, C4, IgM, IgG, CD4/CD8, and lungs' images ready before the clinical study;
* The Participants must repeat the evaluation experiment during and at the end of the clinical study.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Individuals with a prior COVID-19 virus infection that no longer shows up from COVID-19 testing;
* Children who are younger than 10-year-old, cannot control themselves to take the medical herbs on time;
* Elders whose age beyond 70-year-old, with severe underline illness;
* COVID-19 virus-infected patients who do not feel willing to take medical herbs;
* Patients diagnosed with COVID-19 virus infection cannot consistently finish the treatment courses for a specific reason;
* Patients diagnosed with COVID-19 virus infection but do not willing to share their information with the public;
* Current or past participation within a specified timeframe in another clinical trial, as warranted by this intervention's administration;
* Severe patients, when there have insufficient normal cells, can be adjusted, with pre-list diseases life-threatening.

Primary outcomes:
measure: recovering damaged organ
timeFrame: 3 weeks
measure: inhibiting inflammation
timeFrame: 3 weeks
measure: preventing the antibody depositing on antigen
timeFrame: 6 weeks
Secondary outcomes:
measure: monitoring the antibody level
timeFrame: 6 weeks
measure: correcting reversed immunity ratio
timeFrame: 6 weeks
measure: tracking the COVID virus marks
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Rockville
country: United States
facility: All Natural Medicine Clinic, LLC
state: Maryland
Study officials:
affiliation: All Natural Medicine Clinic, LLC
name: Wanzhu Hou, CMD,MD(CN)
role: PRINCIPAL_INVESTIGATOR
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