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

Depression Clinical Trial

— sequelae  

Official title:

Treating Sequalae Caused by Post-acute Sequelae of SARS (Severe Acute Respiratory Syndrome)-CoV-2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846010
• Other study ID #: CHM2282395-2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2021
• Source: All Natural Medicine Clinic, LLC
• Contact: Wanzhu Hou, CMD
• Phone: (301)770-4480
• Email: info[@]anmedicine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Anxiety Disorders
• Arthritis, Infectious
• Arthritis, Reactive
• Bipolar Disorder
• Communicable Diseases
• Depression
• Depression, Anxiety
• Depression, Bipolar
• Depressive Disorder
• Disease
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• GERD
• Glomerulonephritis
• Hepatitis
• Hypothyroidism
• Infection
• Insomnia
• Neuralgia
• Neuritis
• Parkinsonian Disorders
• Post Infection Glomerulonephritis
• Post Infectious Osteoarthritis
• Post-Infectious Arthritis
• Post-Infectious Disorder (Disorder)
• Post-Infectious Hypothyroidism
• Post-Infectious Parkinsonism
• Post-Infectious Peripheral Neuralgia
• Post-Infectious Polyneuritis
• Sequelae of; Infection

Intervention

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),
• 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).
• 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)
• 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).
• PurClo
(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos)
• PurInf
(1) lei gong teng (Tripterygii wilfordii Radix), Huang Qin (Scutellariae Radix), Huang Lian (Coptidis Rhizoma), Huang Bai (Phellodendri Cortex), Zhi Zi (Gardeniae Fructus).
• 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)

Locations

Country	Name	City	State
United States	All Natural Medicine Clinic, LLC	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
All Natural Medicine Clinic, LLC

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Review. — View Citation

Honda T, Egen JG, Lämmermann T, Kastenmüller 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

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. Review. — View 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). pii: E762. doi: 10.3390/v11080762. Review. — View 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. Review. — View Citation

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

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

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Monitoring emotion changing	measuring anxiety, depression, bipolar feeling by Visual Analog Score (VAS)	3 months as a course.
Secondary	Checking heart burn symptom	Measuring stomach reflux symptom by Visual Analog Score (VAS)	3 months as a course.
Secondary	Monitoring thyroid function	Measuring thyroid hormone3, 4 (T3,T4), thyroid-stimulating hormone (TSH) level	3 months as a course
Secondary	Monitoring liver function	Measuring alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase (ALP) recovering	3 months as a course
Secondary	Monitoring kidney function	Measuring estimated glomerular filtration rate (eGFR), creatinine (Cr.) level	3 months as a course

External 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