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

NCT04790240 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CHM2282395-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• monitoring the antibody level

  6 weeks

• correcting reversed immunity ratio

  6 weeks

• tracking the COVID virus marks

  3 weeks

Study Arms (3)

Inflammation (I)

ACTIVE COMPARATOR

1. Upper respiratory inflammation. 2. Fever. 3. Lower respiration inflammation.

Dietary Supplement: Inflammation (I); Drug: Standard of care

Inflammation (II)

ACTIVE COMPARATOR

Cough, chest pain

Dietary Supplement: Inflammation (II); Drug: Standard of care

Inflammation (III)

ACTIVE COMPARATOR

1. Metabolites 2. Clots

Dietary Supplement: Inflammation (III); Drug: Standard of care

Interventions

Inflammation (I) DIETARY_SUPPLEMENT

1. 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 2. high fever (PurInf (II)): Bupleuri Radix 3g, Scutellariae Radix 2.4g, Gypsum fibrosum 4g, Anemarrhenae Rhizoma 3g 3. 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

Also known as: PurInf (I), PurInf (II), PurInf(III)

Inflammation (I)

Inflammation (II) DIETARY_SUPPLEMENT

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

Also known as: PurCo

Inflammation (II)

Inflammation (III) DIETARY_SUPPLEMENT

1. 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 2. 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

Also known as: PurPhl, PurClo

Inflammation (III)

Standard of care DRUG

remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab \& Imdevimab.

Also known as: Medications

Inflammation (I); Inflammation (II); Inflammation (III)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All Natural Medicine Clinic, LLC: lead

Study Sites (1)

All Natural Medicine Clinic, LLC

Rockville, Maryland, 20852-2235, United States

RECRUITING

Related Publications (10)

• Wannzhu Hou Cellular Structure and its Function is the key for heeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014

  BACKGROUND

• 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.

  PMID: 24795718 BACKGROUND

• 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.

  PMID: 32802404 BACKGROUND

• 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.

  PMID: 8666349 BACKGROUND

• 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.

  PMID: 23263184 BACKGROUND

• 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.

  PMID: 29669994 BACKGROUND

• 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.

  PMID: 21293466 BACKGROUND

• Samuels N. Herbal remedies and anticoagulant therapy. Thromb Haemost. 2005 Jan;93(1):3-7. doi: 10.1160/TH04-05-0285.

  PMID: 15630483 BACKGROUND

• 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.

  PMID: 30776316 BACKGROUND

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

  RESULT

Related Links

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

MeSH Terms

Conditions

COVID-19; Virus Diseases; Infections; Inflammation; Thrombosis; Pneumonia, Viral; Fever; Cough

Interventions

Standard of Care; Dosage Forms

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Wanzhu Hou, CMD,MD(CN)

  All Natural Medicine Clinic, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanzhu Hou, CMD, MD(CN)

CONTACT

1(301)770-4480; info@anmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 10, 2021
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)