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Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2 (sequelae)

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ClinicalTrials.gov Identifier: NCT04846010
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Wanzhu Hou, All Natural Medicine Clinic, LLC

Brief Summary:
Post-acute sequelae of SARS-CoV-2 infection can cause multiple system function disorders, and complicated symptoms last for an extended period. The virus can cause this continued infection, or the virus causes immune system function disorder and post-infectious autoimmune disease. The clinical symptoms can be smell loss, taste loss to liver function disorder, kidney function failure, different. No matter how complicated the systems showed in the clinic, all of the symptoms are due to the specific cells being damaged. Our clinical study is focused on recovering the damaged structure and function of the cells that could restore the organ function back to normal or close to normal

Condition or disease Intervention/treatment Phase
Sequelae of; Infection Post Infection Glomerulonephritis Post-Infectious Peripheral Neuralgia Post-Infectious Disorder (Disorder) Post-Infectious Arthritis Post-Infectious Polyneuritis Post-Infectious Parkinsonism Post-Infectious Hypothyroidism Post Infectious Osteoarthritis Anxiety Disorders Depression Depression, Anxiety Depression, Bipolar Insomnia GERD Gastro Esophageal Reflux Hepatitis Glomerulonephritis Combination Product: PurWet Combination Product: FurFat Combination Product: PurApo Combination Product: PurPhl Combination Product: PurClo Combination Product: PurInf Combination Product: Smoliv Phase 1 Phase 2

Detailed Description:

SARS-CoV-2 caused sequela is a pathological condition, and specific cells are damaged from a prior disease, injury, or attack. Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) is caused by an infection of SARS-CoV-2 and COVID-19 virus. The virus or virus-triggered disorder immunity attacks target tissue(s) and organ(s). No matter name of the virus and the cells, tissue(s), or organ(s), they all belong to the category of antigen and cause an immune response; this can induce inflammation or not depending on the immune system tolerance . While older patients may have an increased risk of developing severe disease or sequelae, young survivors have also reported symptoms months after acute infection of SARS-CoV-2, reported by the British Lung Foundation. Some infected people, referred to as long-haulers, experience a long period of symptoms. Characterization of the etiology and pathophysiology of late sequelae is underway and may reflect organ damage from the acute infection phase; manifestations of a persistent hyperinflammatory state even perform as autoimmune diseases. Rheumatic disease can also occur during the infection of COVID. Ongoing viral activity indicates an inadequate antibody response. Factors in addition to acute illness that may further complicate the picture include physical deconditioning at baseline or after a long disease course, pre-COVID-19 comorbidities, and psychological sequelae following a long or difficult disease course relating to lifestyle changes due to the pandemic. Likely, the persistent sequelae of COVID-19 represent multiple syndromes resulting from distinct pathophysiological processes along the spectrum of disease. So far, no specific medicine has been identified for treating the COVID-19 virus and post-acute sequelae of SARS-CoV-2. Due to the difficulty treating either SARS-CoV-2 or its caused sequelae, there is a very pessimistic suggestion: People must live with COVID-19 forever. Most people who contract coronavirus disease 2019 (COVID-19) infection recover entirely within a few weeks. However, the long-haulers continue to experience symptoms after their initial recovery. This condition has been called post-COVID-19 syndrome or "long COVID-19." Older people and people with many severe medical conditions are the most likely to experience lingering COVID-19 symptoms, but even young, otherwise healthy people can feel unwell for weeks to months after infection. The most common signs and symptoms that linger over time include fatigue, shortness of breath, cough, joint pain, and chest pain. Other long-term signs and symptoms may include muscle pain or headache, fast or pounding heartbeat, loss of smell or taste, memory and concentration or sleep problems, and rash or hair loss, the Mayo Clinic reported.

Virus infections have been long associated with autoimmune diseases, whether multiple sclerosis, diabetes, or myocarditis. Three potential mechanisms for virus-induced autoimmune disease or virus-induced immunopathology are molecular mimicry, bystander activation, and persistent virus infection.

Those prolonged symptoms are consistent with the internal physical pathological process. That can be the virus infection continuing, or the infection triggered an immune reaction in one or more physical locations when a person became infected with the COVID-19 virus.

Here is the critical point: when the structure of cells is destroyed, the result is the affected cell's function will be lost. Does the etiology directly destroy the antigen, or the virus trigger the disorder immunity to destroy the antigen? The results are the same: the antigen is under inflammation. Returning the damaged cells (antigen) to normal or close to normal states is the key to saving lives.

This raises questions concerning how can we protect those cells from becoming damaged and how can we return injured cells to their normal function? Regardless of whether the cell has been damaged directly by the virus infection, or another reason like disordered immunity, my clinical research will show how to solve those medical problems.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This clinical study designed with a sequential assignment: participants receive their medical herbs depending on their pathological states; through one course of the treatment, we will review their symptoms and corresponding indicators of visceral damage。
Masking: None (Open Label)
Masking Description: To restore the damaged structure and function of cells, participants come for the treatment with their diagnosis and experiment medics from their conventional practitioners. There have no masking for anybody.
Primary Purpose: Treatment
Official Title: Treating Sequalae Caused by Post-acute Sequelae of SARS (Severe Acute Respiratory Syndrome)-CoV-2 Infection
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : October 1, 2022


Arm Intervention/treatment
Active Comparator: antigen
The antigen is the cell that is destroyed by inflammation, which can perform as swollen, fatty, apoptosis, necrosis, and lethal pathological states. Some pathological cells can be saved and returned to customary conditions, like swollen, fatty, early apoptosis, but necrosis, lethal.
Combination Product: PurWet
(1) cang zhu (Atractylodis Rhizoma), bai (zhu Atractylodis macrocephalae Rhizoma), dang shen (Codonopsis Radix), huang qi (Astragali Radix), Fu ling (Poria), Zhu ling (polyporus), Ze xie (Alismatis Rhizoma), Yi yi ren (Coicis Semen), gan cao (Glycyrrhizae Radix),

Combination Product: FurFat
(2).shan zha (Crataegi Fructus), Jue Ming Zi (Cassiae Semen), He ye (Nelumbinis Folium), Da huang (Rhei Radix et Rhizoma), Ze xie (Alismatis Rhizoma), dan shen ( Salviae miltiorrhizae Radix).

Combination Product: PurApo
(3)Sheng Di Huang (Rehmanniae Radix), Xuan Shen (Scrophulariae Radix), mai men dong (Ophiopogonis Radix), shan zhu yu (Corni Fructus), shan yao (Dioscoreae Rhizoma), sha yuan zi (Astragali complanati Semen), ci ji li (Tribuli Fructus), nu zhen zi (Ligustri lucidi Fructus)

Combination Product: PurPhl
(4) chen pi (Citri reticulatae Pericarpium), hua ju hong (Citri grandis Exocartium rubrum), zhi shi (Aurantii Fructus immaturu), zhi ban xia (Pinelliae Rhizoma preparatum), zhi tian nan xing (Arisaematis Rhizoma preparatum),sha ren (Amoni Fructus), Gua lou (Trichosanthis Fructus), Chuan bei mu ( Fritillatiae cirrhosae Bulbu), Fu ling ( Poria), Da huang ( Rhei Radix et Rhizoma).

Active Comparator: Internal environment
The internal environment is critical to the damaged cells recovering. Mainly it is covered by two major parts: metabolites and thrombus.
Combination Product: PurClo
(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos)

Active Comparator: Communication between cells
The communication between organs, cells, helps the damaged cells recover and reduce symptoms.
Combination Product: PurInf
(1) lei gong teng (Tripterygii wilfordii Radix), Huang Qin (Scutellariae Radix), Huang Lian (Coptidis Rhizoma), Huang Bai (Phellodendri Cortex), Zhi Zi (Gardeniae Fructus).

Combination Product: Smoliv
(2). Vagus never communicates with LES: yu jin (Curcumae Radix), Chai Hu (Bupleuri Radix), chi shao (Paeoniae Radix rubra), Mu Dan Pi (Moutan Cortex), chuan lian zi (Toosendan Fructus), long gu (Fossilia Ossis Mastodi), mu li (Ostreae Concha)




Primary Outcome Measures :
  1. Monitoring symptoms [ Time Frame: 3 months as a course ]
    Measuring the symptoms of chest pain, cough, loss of smell, loss of taste by Visual Analog Score (VAS)


Secondary Outcome Measures :
  1. Monitoring emotion changing [ Time Frame: 3 months as a course. ]
    measuring anxiety, depression, bipolar feeling by Visual Analog Score (VAS)

  2. Checking heart burn symptom [ Time Frame: 3 months as a course. ]
    Measuring stomach reflux symptom by Visual Analog Score (VAS)

  3. Monitoring thyroid function [ Time Frame: 3 months as a course ]
    Measuring thyroid hormone3, 4 (T3,T4), thyroid-stimulating hormone (TSH) level

  4. Monitoring liver function [ Time Frame: 3 months as a course ]
    Measuring alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase (ALP) recovering

  5. Monitoring kidney function [ Time Frame: 3 months as a course ]
    Measuring estimated glomerular filtration rate (eGFR), creatinine (Cr.) level



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participants must receive medical herbs as a treatment method;
  • Participants are not limited by age, sex, race, or location;
  • Participants are including infants;
  • Participants are including pregnant woman;
  • The participants had an infection history of SARS-CoV-2 in past one month;
  • The participants provide SARS-CoV-s diagnoses (Molecular or Antigen). Test was *positive, now hold negative reports
  • Participants hold reports of immune system medics, like immunoglobulin M (IgM), immunoglobulin G (IgG);
  • Reports that is evidence of specific organ damaged, including assay reports or image reports
  • Participants must agree to take medical herbs for at least 3 months as one course continually;
  • Participants must agree to repeat the assay and image test to monitor the treatment results;
  • Participants must report their Manifestations clearly to investigators;
  • Participants must agree to continue the next course of the treatment after the evaluation if it is necessary;
  • The treatment goal is to become symptom-free, and experiment assays went to normal

Exclusion Criteria:

  • Participants don't want to take medical herbs;
  • Participants have symptoms of sequelae but is not caused by SARS-CoV-2 (COVID-19);
  • Participants have not symptoms after COVID-19 infection, no assays abnormal either;
  • Participants don't want to repeat the experiment assays;
  • Participants are in E.R. or ICU during the application or enrollment;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846010


Contacts
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Contact: Wanzhu Hou, CMD (301)770-4480 info@anmedicine.com

Locations
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United States, Maryland
All Natural Medicine Clinic, LLC Recruiting
Rockville, Maryland, United States, 20852-2235
Contact: Adaobi Mgbodille    301-770-4480    info@anmedicine.com   
Sponsors and Collaborators
All Natural Medicine Clinic, LLC
Investigators
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Principal Investigator: Wanzhu Hou, CMD All Natural Medicine Clinic, LLC
Additional Information:
Publications:
Wanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011
Wannzhu Hou Cellular Structure and its Function is the key for keeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014

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Responsible Party: Wanzhu Hou, President, All Natural Medicine Clinic, LLC
ClinicalTrials.gov Identifier: NCT04846010    
Other Study ID Numbers: CHM2282395-2
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Medical herbs are not directing immunity only, but also recover the damaged structure and function of cells that be destroyed by inflammation. We will publish the process of the treatment as soon as we can.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: We will continually publish clinical case study online.
Access Criteria:

If you are a conventional medical practitioner, you can open it, and you will experience the different practice in clinic.

If you are a helictical medical practitioner, you can learn how integrative medicine practice in clinic.

URL: https://anmedicine.com/blog/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wanzhu Hou, All Natural Medicine Clinic, LLC:
treatment of Covid-19 virus infection
COVID stress syndrome
COVID19 stress syndrome
sequelae
sequels
loss of smell
loss of taste
emotion disorder
panic disorder
Post-Traumatic Stress Disorder (PTSD)
Depression
Anxiety
Heartburn
GERD
Gastroesophageal reflux disease
Sleep Disorders
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis, Reactive
Gastroesophageal Reflux
Neuralgia
Parkinsonian Disorders
Neuritis
Glomerulonephritis
Hypothyroidism
Disease
Depression
Depressive Disorder
Anxiety Disorders
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Digestive System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Thyroid Diseases
Endocrine System Diseases