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

NCT04846010 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: CHM2282395-2
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Monitoring symptoms

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

  3 months as a course

Secondary Outcomes (5)

• Monitoring emotion changing

  3 months as a course.

• Checking heart burn symptom

  3 months as a course.

• Monitoring thyroid function

  3 months as a course

• Monitoring liver function

  3 months as a course

• Monitoring kidney function

  3 months as a course

Study Arms (3)

antigen

ACTIVE COMPARATOR

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; Combination Product: FurFat; Combination Product: PurApo; Combination Product: PurPhl

Internal environment

ACTIVE COMPARATOR

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

Combination Product: PurClo

Communication between cells

ACTIVE COMPARATOR

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

Combination Product: PurInf; Combination Product: Smoliv

Interventions

PurWet COMBINATION_PRODUCT

(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),

antigen

FurFat COMBINATION_PRODUCT

(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).

antigen

PurApo COMBINATION_PRODUCT

(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)

antigen

PurPhl COMBINATION_PRODUCT

(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).

antigen

PurClo COMBINATION_PRODUCT

(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos)

Internal environment

PurInf COMBINATION_PRODUCT

(1) lei gong teng (Tripterygii wilfordii Radix), Huang Qin (Scutellariae Radix), Huang Lian (Coptidis Rhizoma), Huang Bai (Phellodendri Cortex), Zhi Zi (Gardeniae Fructus).

Communication between cells

Smoliv COMBINATION_PRODUCT

(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)

Communication between cells

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

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 (11)

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

  BACKGROUND

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

  BACKGROUND

• Zigmond E, Varol C, Farache J, Elmaliah E, Satpathy AT, Friedlander G, Mack M, Shpigel N, Boneca IG, Murphy KM, Shakhar G, Halpern Z, Jung S. Ly6C hi monocytes in the inflamed colon give rise to proinflammatory effector cells and migratory antigen-presenting cells. Immunity. 2012 Dec 14;37(6):1076-90. doi: 10.1016/j.immuni.2012.08.026. Epub 2012 Dec 6.

  PMID: 23219392 BACKGROUND

• 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.

  PMID: 30421030 BACKGROUND

• 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.

  PMID: 33177481 BACKGROUND

• 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.

  PMID: 32991251 BACKGROUND

• Schvartz A, Belot A, Kone-Paut I. Pediatric Inflammatory Multisystem Syndrome and Rheumatic Diseases During SARS-CoV-2 Pandemic. Front Pediatr. 2020 Dec 4;8:605807. doi: 10.3389/fped.2020.605807. eCollection 2020.

  PMID: 33344389 BACKGROUND

• 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.

  PMID: 31430946 BACKGROUND

• Ploumpidis D. Living with covid-19. Psychiatriki. 2020 Jul-Sep;31(3):197-200. doi: 10.22365/jpsych.2020.313.197. English, Greek, Modern.

  PMID: 33099460 BACKGROUND

• 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.

  PMID: 16418524 BACKGROUND

• 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.

  PMID: 24440150 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Infections; Post-Infectious Disorders; Arthritis, Reactive; Guillain-Barre Syndrome; Anxiety Disorders; Depression; Bipolar Disorder; Sleep Initiation and Maintenance Disorders; Gastroesophageal Reflux; Hepatitis; Glomerulonephritis; COVID-19 stress syndrome; Anosmia; Ageusia; Panic Disorder; Stress Disorders, Post-Traumatic; Heartburn; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis, Infectious; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Taste Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Signs and Symptoms, Digestive

Study Officials

• Wanzhu Hou, CMD

  All Natural Medicine Clinic, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanzhu Hou, CMD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: 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。

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 15, 2021
• Study Start: March 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)