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Covid19 Virus InfectionPhase 1/2COVIDNCT04790240

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

A Phase 1/2 study testing Inflammation (I), Inflammation (II) and Inflammation (III) in people with Covid19 Virus Infection, run by All Natural Medicine Clinic, LLC at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Covid19 Virus Infection
What is being tested?
Inflammation (I), Inflammation (II) and Inflammation (III)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 30 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wanzhu Hou, CMD, MD(CN) contact

1(301)770-4480

info@anmedicine.com

United States1 site, 1 recruiting
  • All Natural Medicine Clinic, LLC

    Rockville, Maryland, 20852-2235

    Naylla Freitas, 301-770-4480, info@anmedicine.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Inflammation (I), Inflammation (II), Inflammation (III), Standard of care
Keywords
Medicinal Herbs, Virus, COVID-19, Coronavirus Disease 2019, Infections, Inflammation, Immunity, Metabolite, clots, thrombus, Viral Pneumonia, Fever, Cough, Chest congestion
Medical subject headings
COVID-19, Virus Diseases, Infections, Inflammation, Thrombosis, Pneumonia, Viral, Fever, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inflammation (I)Dietary supplement

    Also called PurInf (I), PurInf (II), PurInf(III)

    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
  • Inflammation (II)Dietary supplement

    Also called PurCo

    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)Dietary supplement

    Also called PurPhl, PurClo

    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

  • Standard of careDrug

    Also called Medications

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

Study groups in NCT04790240
Study groupRoleWhat they receive
Inflammation (I)Active comparator1. Upper respiratory inflammation. 2. Fever. 3. Lower respiration inflammation.
Receives: Dietary Supplement: Inflammation (I); Drug: Standard of care
Inflammation (II)Active comparatorCough, chest pain
Receives: Dietary Supplement: Inflammation (II); Drug: Standard of care
Inflammation (III)Active comparator1. Metabolites 2. Clots
Receives: Dietary Supplement: Inflammation (III); Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recovering damaged organ

    comparing imagen of lungs

    Measured: 3 weeks

  2. inhibiting inflammation

    comparing C-reactive protein (CRP)

    Measured: 3 weeks

  3. preventing the antibody depositing on antigen

    measuring complement: C3, C4

    Measured: 6 weeks

Secondary outcomes (3)
  1. monitoring the antibody level

    measuring immunoglobulin M (IgM), immunoglobulin G (IgG)

    Measured: 6 weeks

  2. correcting reversed immunity ratio

    measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8)

    Measured: 6 weeks

  3. tracking the COVID virus marks

    SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start1 Jan 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Care provider
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04790240
Sponsor's protocol ID
CHM2282395-1
Acronym
COVID
Status last verified
Feb 2025
First submitted
23 Feb 2021
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 24795718
  • 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.

    PubMed 32802404
  • 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.

    PubMed 8666349
  • 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.

    PubMed 23263184
  • 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.

    PubMed 29669994
  • 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.

    PubMed 21293466
  • Samuels N. Herbal remedies and anticoagulant therapy. Thromb Haemost. 2005 Jan;93(1):3-7. doi: 10.1160/TH04-05-0285.

    PubMed 15630483
  • 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.

    PubMed 30776316
  • Wanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Inflammation (I), Inflammation (II) and Inflammation (III) in people with Covid19 Virus Infection, run by All Natural Medicine Clinic, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wanzhu Hou, CMD, MD(CN) (1(301)770-4480, info@anmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recovering damaged organ (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04790240, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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