Recruiting
Phase 1
Phase 2

Medical Herbs

Sponsor:

All Natural Medicine Clinic, LLC

Code:

NCT04790240

Conditions

Covid19 Virus Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Inflammation (I)

Inflammation (II)

Inflammation (III)

Standard of care

Study Details

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

Study ID

NCT04790240

Start date

Jan 1, 2025

Status verified date

Feb, 2025

Completion date

May 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Inflammation (I)

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

active comparator: Inflammation (II)

Cough, chest pain

active comparator: Inflammation (III)

1. Metabolites
2. Clots

Interventions

Inflammation (I)

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)

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)

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 care

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

Primary outcome measure

  • recovering damaged organ [ Time Frame: 3 weeks ]
  • inhibiting inflammation [ Time Frame: 3 weeks ]
  • preventing the antibody depositing on antigen [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Wanzhu Hou, CMD, MD(CN)

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

Locations

All Natural Medicine Clinic, LLC

Recruiting

Rockville, Maryland, United States, 20852-2235

Contacts

Naylla Freitas

301-770-4480info@anmedicine.com

More Information

Sponsor

All Natural Medicine Clinic, LLC

Last update posted

Feb 19, 2025

Last verified

Feb, 2025

Keywords

  • Medicinal Herbs
  • Virus
  • COVID-19
  • Coronavirus Disease 2019
  • Infections
  • Inflammation
  • Immunity
  • Metabolite
  • clots
  • thrombus
  • Viral Pneumonia
  • Fever
  • Cough
  • Chest congestion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by All Natural Medicine Clinic, LLC on 2025-02-19.