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

The Trial Uses Medicinal Herbs to Direct T Cells to Engulf the COVID-19 Virus and Protect the Organs Well

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19 Virus Infection
• Intervention / Treatment: Dietary supplement: Inflammation (I); Drug: Standard of care; Dietary supplement: Inflammation (II); Dietary supplement: Inflammation (III)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Wanzhu Hou, CMD, MD(CN); Phone Number: 1(301)770-4480; Email: info@anmedicine.com

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20852-2235
      • Recruiting
      • All Natural Medicine Clinic, LLC
      • Contact: Naylla Freitas; Phone Number: 301-770-4480; Email: info@anmedicine.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Inflammation (I); Upper respiratory inflammation.; Fever.; Lower respiration inflammation.	Dietary supplement: Inflammation (I); 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; Other Names: PurInf (I), PurInf (II), PurInf(III); Drug: Standard of care; remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.; Other Names: Medications
ACTIVE_COMPARATOR: Inflammation (II); Cough, chest pain	Drug: Standard of care; remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.; Other Names: Medications; Dietary supplement: Inflammation (II); 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; Other Names: PurCo
ACTIVE_COMPARATOR: Inflammation (III); Metabolites; Clots	Drug: Standard of care; remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.; Other Names: Medications; Dietary supplement: Inflammation (III); 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; Other Names: PurPhl, PurClo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovering damaged organ	comparing imagen of lungs	3 weeks
inhibiting inflammation	comparing C-reactive protein (CRP)	3 weeks
preventing the antibody depositing on antigen	measuring complement: C3, C4	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monitoring the antibody level	measuring immunoglobulin M (IgM), immunoglobulin G (IgG)	6 weeks
correcting reversed immunity ratio	measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8)	6 weeks
tracking the COVID virus marks	SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing	3 weeks

Collaborators and Investigators

• Sponsor: All Natural Medicine Clinic, LLC
• Investigators: Principal Investigator: Wanzhu Hou, CMD,MD(CN), All Natural Medicine Clinic, LLC

Publications and helpful links

General Publications

• Wannzhu Hou Cellular Structure and its Function is the key for heeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014
• Rosendahl Huber S, van Beek J, de Jonge J, Luytjes W, van Baarle D. T cell responses to viral infections - opportunities for Peptide vaccination. Front Immunol. 2014 Apr 16;5:171. doi: 10.3389/fimmu.2014.00171. eCollection 2014.
• Zhou LK, Zhou Z, Jiang XM, Zheng Y, Chen X, Fu Z, Xiao G, Zhang CY, Zhang LK, Yi Y. Absorbed plant MIR2911 in honeysuckle decoction inhibits SARS-CoV-2 replication and accelerates the negative conversion of infected patients. Cell Discov. 2020 Aug 5;6(1):54. doi: 10.1038/s41421-020-00197-3. eCollection 2020. No abstract available.
• Peters M. Actions of cytokines on the immune response and viral interactions: an overview. Hepatology. 1996 Apr;23(4):909-16. doi: 10.1053/jhep.1996.v23.ajhep0230909. No abstract available.
• Zhou H, Sun L, Yang XL, Schimmel P. ATP-directed capture of bioactive herbal-based medicine on human tRNA synthetase. Nature. 2013 Feb 7;494(7435):121-4. doi: 10.1038/nature11774. Epub 2012 Dec 23.
• Dosch M, Gerber J, Jebbawi F, Beldi G. Mechanisms of ATP Release by Inflammatory Cells. Int J Mol Sci. 2018 Apr 18;19(4):1222. doi: 10.3390/ijms19041222.
• Chen RJ, Jinn TR, Chen YC, Chung TY, Yang WH, Tzen JT. Active ingredients in Chinese medicines promoting blood circulation as Na+/K+ -ATPase inhibitors. Acta Pharmacol Sin. 2011 Feb;32(2):141-51. doi: 10.1038/aps.2010.197.
• Samuels N. Herbal remedies and anticoagulant therapy. Thromb Haemost. 2005 Jan;93(1):3-7. doi: 10.1160/TH04-05-0285.
• Soni S, O'Dea KP, Tan YY, Cho K, Abe E, Romano R, Cui J, Ma D, Sarathchandra P, Wilson MR, Takata M. ATP redirects cytokine trafficking and promotes novel membrane TNF signaling via microvesicles. FASEB J. 2019 May;33(5):6442-6455. doi: 10.1096/fj.201802386R. Epub 2019 Feb 18.
• Wanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011

Helpful Links

• We widely treat and research infected and non-infected diseases based on recovering the damaged structure and function of cells.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; COVID-19; Fever; Immunity; Coronavirus Disease 2019; Cough; Virus; Infections; Metabolite; thrombus; Viral Pneumonia; Medicinal Herbs; clots; Chest congestion
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CHM2282395-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No