Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2 (sequelae)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04846010|
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : May 26, 2021
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|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.|
|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|
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)
- 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)
- Monitoring emotion changing [ Time Frame: 3 months as a course. ]measuring anxiety, depression, bipolar feeling by Visual Analog Score (VAS)
- Checking heart burn symptom [ Time Frame: 3 months as a course. ]Measuring stomach reflux symptom by Visual Analog Score (VAS)
- Monitoring thyroid function [ Time Frame: 3 months as a course ]Measuring thyroid hormone3, 4 (T3,T4), thyroid-stimulating hormone (TSH) level
- Monitoring liver function [ Time Frame: 3 months as a course ]Measuring alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase (ALP) recovering
- Monitoring kidney function [ Time Frame: 3 months as a course ]Measuring estimated glomerular filtration rate (eGFR), creatinine (Cr.) level
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
|Contact: Wanzhu Hou, CMD||(301)email@example.com|
|United States, Maryland|
|All Natural Medicine Clinic, LLC||Recruiting|
|Rockville, Maryland, United States, 20852-2235|
|Contact: Adaobi Mgbodille 301-770-4480 firstname.lastname@example.org|
|Principal Investigator:||Wanzhu Hou, CMD||All Natural Medicine Clinic, LLC|