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

Covid19 Virus Infection Clinical Trial

— COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790240
• Other study ID #: CHM2282395-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: May 2021
• Source: All Natural Medicine Clinic, LLC
• Contact: Wanzhu Hou, CMD, MD(CN)
• Phone: 1(301)770-4480
• Email: info[@]anmedicine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19 Virus Infection

Intervention

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
• 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
• 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

Drug:
• Standard of care
remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.

Locations

Country	Name	City	State
United States	All Natural Medicine Clinic, LLC	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
All Natural Medicine Clinic, LLC

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Review. — View Citation

Michel Dosch, et al. Mechanisms of ATP Release by Inflammatory Cells. International Journal of Molecular science. 2018 Apr; 19(4): 1222

Peters M. Actions of cytokines on the immune response and viral interactions: an overview. Hepatology. 1996 Apr;23(4):909-16. Review. — View Citation

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. Review. — View Citation

Samuels N. Herbal remedies and anticoagulant therapy. Thromb Haemost. 2005 Jan;93(1):3-7. Review. — View Citation

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. — View 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

Wanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011

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. — View Citation

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;6:54. doi: 10.1038/s41421-020-00197-3. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovering damaged organ	comparing imagen of lungs	3 weeks
Primary	inhibiting inflammation	comparing C-reactive protein (CRP)	3 weeks
Primary	preventing the antibody depositing on antigen	measuring complement: C3, C4	6 weeks
Secondary	monitoring the antibody level	measuring immunoglobulin M (IgM), immunoglobulin G (IgG)	6 weeks
Secondary	correcting reversed immunity ratio	measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8)	6 weeks
Secondary	tracking the COVID virus marks	SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing	3 weeks

External Links

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