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

Primary Purpose

Sequelae of; Infection, Post Infection Glomerulonephritis, Post-Infectious Peripheral Neuralgia

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PurWet
FurFat
PurApo
PurPhl
PurClo
PurInf
Smoliv
Sponsored by
All Natural Medicine Clinic, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sequelae of; Infection focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • All Natural Medicine Clinic, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

antigen

Internal environment

Communication between cells

Arm Description

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.

The internal environment is critical to the damaged cells recovering. Mainly it is covered by two major parts: metabolites and thrombus.

The communication between organs, cells, helps the damaged cells recover and reduce symptoms.

Outcomes

Primary Outcome Measures

Monitoring symptoms
Measuring the symptoms of chest pain, cough, loss of smell, loss of taste by Visual Analog Score (VAS)

Secondary Outcome Measures

Monitoring emotion changing
measuring anxiety, depression, bipolar feeling by Visual Analog Score (VAS)
Checking heart burn symptom
Measuring stomach reflux symptom by Visual Analog Score (VAS)
Monitoring thyroid function
Measuring thyroid hormone3, 4 (T3,T4), thyroid-stimulating hormone (TSH) level
Monitoring liver function
Measuring alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase (ALP) recovering
Monitoring kidney function
Measuring estimated glomerular filtration rate (eGFR), creatinine (Cr.) level

Full Information

First Posted
March 31, 2021
Last Updated
May 23, 2021
Sponsor
All Natural Medicine Clinic, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04846010
Brief Title
Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2
Acronym
sequelae
Official Title
Treating Sequalae Caused by Post-acute Sequelae of SARS (Severe Acute Respiratory Syndrome)-CoV-2 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All Natural Medicine Clinic, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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.
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antigen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internal environment
Arm Type
Active Comparator
Arm Description
The internal environment is critical to the damaged cells recovering. Mainly it is covered by two major parts: metabolites and thrombus.
Arm Title
Communication between cells
Arm Type
Active Comparator
Arm Description
The communication between organs, cells, helps the damaged cells recover and reduce symptoms.
Intervention Type
Combination Product
Intervention Name(s)
PurWet
Intervention Description
(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),
Intervention Type
Combination Product
Intervention Name(s)
FurFat
Intervention Description
(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).
Intervention Type
Combination Product
Intervention Name(s)
PurApo
Intervention Description
(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)
Intervention Type
Combination Product
Intervention Name(s)
PurPhl
Intervention Description
(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).
Intervention Type
Combination Product
Intervention Name(s)
PurClo
Intervention Description
(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos)
Intervention Type
Combination Product
Intervention Name(s)
PurInf
Intervention Description
(1) lei gong teng (Tripterygii wilfordii Radix), Huang Qin (Scutellariae Radix), Huang Lian (Coptidis Rhizoma), Huang Bai (Phellodendri Cortex), Zhi Zi (Gardeniae Fructus).
Intervention Type
Combination Product
Intervention Name(s)
Smoliv
Intervention Description
(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 Measure Information:
Title
Monitoring symptoms
Description
Measuring the symptoms of chest pain, cough, loss of smell, loss of taste by Visual Analog Score (VAS)
Time Frame
3 months as a course
Secondary Outcome Measure Information:
Title
Monitoring emotion changing
Description
measuring anxiety, depression, bipolar feeling by Visual Analog Score (VAS)
Time Frame
3 months as a course.
Title
Checking heart burn symptom
Description
Measuring stomach reflux symptom by Visual Analog Score (VAS)
Time Frame
3 months as a course.
Title
Monitoring thyroid function
Description
Measuring thyroid hormone3, 4 (T3,T4), thyroid-stimulating hormone (TSH) level
Time Frame
3 months as a course
Title
Monitoring liver function
Description
Measuring alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase (ALP) recovering
Time Frame
3 months as a course
Title
Monitoring kidney function
Description
Measuring estimated glomerular filtration rate (eGFR), creatinine (Cr.) level
Time Frame
3 months as a course

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanzhu Hou, CMD
Phone
(301)770-4480
Email
info@anmedicine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanzhu Hou, CMD
Organizational Affiliation
All Natural Medicine Clinic, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
All Natural Medicine Clinic, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852-2235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adaobi Mgbodille
Phone
301-770-4480
Email
info@anmedicine.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
We will continually publish clinical case study online.
IPD Sharing 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.
IPD Sharing URL
https://anmedicine.com/blog/
Citations:
Citation
Wanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011
Results Reference
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Wannzhu Hou Cellular Structure and its Function is the key for keeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014
Results Reference
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PubMed Identifier
23219392
Citation
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Results Reference
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Citation
Jurewicz MM, Stern LJ. Class II MHC antigen processing in immune tolerance and inflammation. Immunogenetics. 2019 Mar;71(3):171-187. doi: 10.1007/s00251-018-1095-x. Epub 2018 Nov 12.
Results Reference
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PubMed Identifier
33177481
Citation
Wang F, Kream RM, Stefano GB. Long-Term Respiratory and Neurological Sequelae of COVID-19. Med Sci Monit. 2020 Nov 1;26:e928996. doi: 10.12659/MSM.928996.
Results Reference
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PubMed Identifier
32991251
Citation
Pollard CA, Morran MP, Nestor-Kalinoski AL. The COVID-19 pandemic: a global health crisis. Physiol Genomics. 2020 Nov 1;52(11):549-557. doi: 10.1152/physiolgenomics.00089.2020. Epub 2020 Sep 29.
Results Reference
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Citation
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Citation
Smatti MK, Cyprian FS, Nasrallah GK, Al Thani AA, Almishal RO, Yassine HM. Viruses and Autoimmunity: A Review on the Potential Interaction and Molecular Mechanisms. Viruses. 2019 Aug 19;11(8):762. doi: 10.3390/v11080762.
Results Reference
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Citation
Ploumpidis D. Living with covid-19. Psychiatriki. 2020 Jul-Sep;31(3):197-200. doi: 10.22365/jpsych.2020.313.197. English, Greek, Modern.
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Citation
Fujinami RS, von Herrath MG, Christen U, Whitton JL. Molecular mimicry, bystander activation, or viral persistence: infections and autoimmune disease. Clin Microbiol Rev. 2006 Jan;19(1):80-94. doi: 10.1128/CMR.19.1.80-94.2006.
Results Reference
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Citation
Honda T, Egen JG, Lammermann T, Kastenmuller W, Torabi-Parizi P, Germain RN. Tuning of antigen sensitivity by T cell receptor-dependent negative feedback controls T cell effector function in inflamed tissues. Immunity. 2014 Feb 20;40(2):235-247. doi: 10.1016/j.immuni.2013.11.017. Epub 2014 Jan 16.
Results Reference
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Links:
URL
http://www.anmedicine.com
Description
Every disease happened on cell's level, recovering the damaged structure and function is the key for healing the sequelae that caused by COVID-19 virus infection

Learn more about this trial

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

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