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Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID) (COVID)

Primary Purpose

Covid19 Virus Infection

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inflammation (I)
Inflammation (II)
Inflammation (III)
Standard of care
Sponsored by
All Natural Medicine Clinic, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 Virus Infection focused on measuring Medicinal Herbs, Virus, COVID-19, Coronavirus Disease 2019, Infections, Inflammation, Immunity, Metabolite, clots, thrombus, Viral Pneumonia, Fever, Cough, Chest congestion

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • All Natural Medicine Clinic, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Inflammation (I)

Inflammation (II)

Inflammation (III)

Arm Description

Upper respiratory inflammation. Fever. Lower respiration inflammation.

Cough, chest pain

Metabolites Clots

Outcomes

Primary Outcome Measures

recovering damaged organ
comparing imagen of lungs
inhibiting inflammation
comparing C-reactive protein (CRP)
preventing the antibody depositing on antigen
measuring complement: C3, C4

Secondary Outcome Measures

monitoring the antibody level
measuring immunoglobulin M (IgM), immunoglobulin G (IgG)
correcting reversed immunity ratio
measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8)
tracking the COVID virus marks
SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing

Full Information

First Posted
February 23, 2021
Last Updated
October 31, 2021
Sponsor
All Natural Medicine Clinic, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04790240
Brief Title
Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID)
Acronym
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All Natural Medicine Clinic, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Virus Infection
Keywords
Medicinal Herbs, Virus, COVID-19, Coronavirus Disease 2019, Infections, Inflammation, Immunity, Metabolite, clots, thrombus, Viral Pneumonia, Fever, Cough, Chest congestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
The participants will be randomly divided into two groups by computer. The conventional practitioners who prescribe medications for the participants will not know who will go to the treatment group. Participants will know which group they are in.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inflammation (I)
Arm Type
Active Comparator
Arm Description
Upper respiratory inflammation. Fever. Lower respiration inflammation.
Arm Title
Inflammation (II)
Arm Type
Active Comparator
Arm Description
Cough, chest pain
Arm Title
Inflammation (III)
Arm Type
Active Comparator
Arm Description
Metabolites Clots
Intervention Type
Dietary Supplement
Intervention Name(s)
Inflammation (I)
Other Intervention Name(s)
PurInf (I), PurInf (II), PurInf(III)
Intervention Description
upper respiratory inflammation (PurInf (I)): Lonicerae Flos 2.4g, Forsythiae Fructus 2.4g, Schizonepetae Herba 2g, Saposhnikoviae Radix 2g, Cicadae Periostracum 1g, Sophorae flavescentis Radix 2.4g, Atractylodis Rhizoma 2g, Angelicae dahuricae Radix 2g, Menthae haplocalycis Herba 2g, Arctii Fructus 2g, Glycyrrhizae Radix 1g high fever (PurInf (II)): Bupleuri Radix 3g, Scutellariae Radix 2.4g, Gypsum fibrosum 4g, Anemarrhenae Rhizoma 3g lower Respiratory system inflammation (PurInf (III)): Scutellariae Radix 2.4g, Coptidis Rhizoma 1g, Phellodendri Cortex 2.4g, Gardeniae Fructus 2.4g, Houttuyniae Herba 4g, Golden Buckwheat 3g
Intervention Type
Dietary Supplement
Intervention Name(s)
Inflammation (II)
Other Intervention Name(s)
PurCo
Intervention Description
Platycodi Radix 2.4g, Peucedani Radix 2.4g, Cynanchi stauntonii Rhizoma 2.4g, Asteris Radix 2.4g, Stemonae Radix 2.4g, Lepidii Descurainiae Semen 2.4g, Plantaginis Semen 2.4g
Intervention Type
Dietary Supplement
Intervention Name(s)
Inflammation (III)
Other Intervention Name(s)
PurPhl, PurClo
Intervention Description
Metabolites, abnormal fluids (PurPhl): Citri reticulatae Pericarpium 1.2g, Citri grandis Exocartium rubrum 2g, Aurantii Fructus immaturu 2g, Pinelliae Rhizoma preparatum 2.4g, Arisaematis Rhizoma preparatum 2.4g, Amoni Fructus 1g, Trichosanthis Fructus 2.4g, Fritillatiae cirrhosae Bulbu 2.4g, Poria 2.4g, Rhei Radix et Rhizoma 1g Capillaries circulation disorder (PurClo): Salviae miltiorrhizae Radix 2.4g, Curcumae Radix 2.4g, Paeoniae Radix rubra 2.4g, Persicae Semen 2.4g, Carthami Flos 2.4g
Intervention Type
Drug
Intervention Name(s)
Standard of care
Other Intervention Name(s)
Medications
Intervention Description
remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.
Primary Outcome Measure Information:
Title
recovering damaged organ
Description
comparing imagen of lungs
Time Frame
3 weeks
Title
inhibiting inflammation
Description
comparing C-reactive protein (CRP)
Time Frame
3 weeks
Title
preventing the antibody depositing on antigen
Description
measuring complement: C3, C4
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
monitoring the antibody level
Description
measuring immunoglobulin M (IgM), immunoglobulin G (IgG)
Time Frame
6 weeks
Title
correcting reversed immunity ratio
Description
measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8)
Time Frame
6 weeks
Title
tracking the COVID virus marks
Description
SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanzhu Hou, CMD, MD(CN)
Phone
1(301)770-4480
Email
info@anmedicine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanzhu Hou, CMD,MD(CN)
Organizational Affiliation
All Natural Medicine Clinic, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
All Natural Medicine Clinic, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852-2235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naylla Freitas
Phone
301-770-4480
Email
info@anmedicine.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
When we finish the project of the clinical study, we will share the individual participant's data (IPD) (but is not personal private to share) when the results in the publication
IPD Sharing Time Frame
The clinical study may start on February 1, 2021; the ending of the say maybe is December 31, 2022. The IPD sharing will begin after the publication in six months.
IPD Sharing Access Criteria
Viruses, including COVID-19, are highly likely to mutate. This capacity makes it particularly challenging to kill the virus with drugs. This clinical study designed two groups, both of they used the same drugs, but the treatment group pluses medical herbs, then both groups parallelly receive the treatment, then compare participants symptoms, blood test of immunity, the lungs imagine, and COVID-19 virus index, the difference in both group, analysis the symptoms and the mechanism.
IPD Sharing URL
http://www.anmedicine.com
Citations:
Citation
Wannzhu Hou Cellular Structure and its Function is the key for heeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014
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Results Reference
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Links:
URL
http://www.anmedicine.com
Description
We widely treat and research infected and non-infected diseases based on recovering the damaged structure and function of cells.

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Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID)

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