Sequelae of; InfectionPhase 1/2sequelaeNCT04846010
Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2
A Phase 1/2 study testing PurWet, FurFat and PurApo in people with Sequelae of; Infection and Post Infection Glomerulonephritis, run by All Natural Medicine Clinic, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sequelae of; Infection, Post Infection Glomerulonephritis, Post-Infectious Peripheral Neuralgia
- What is being tested?
- PurWet, FurFat and PurApo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
All Natural Medicine Clinic, LLC
Rockville, Maryland, 20852-2235
Adaobi Mgbodille, 301-770-4480, info@anmedicine.com
About this study
Official title: Treating Sequalae Caused by Post-acute Sequelae of SARS (Severe Acute Respiratory Syndrome)-CoV-2 Infection
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
Read the 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.
- Conditions
- Sequelae of; Infection, Post Infection Glomerulonephritis, Post-Infectious Peripheral Neuralgia, Post-Infectious Disorder (Disorder), Post-Infectious Arthritis, Post-Infectious Polyneuritis
- Being tested
- PurWet, FurFat, PurApo, PurPhl, PurClo
- 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
- Medical subject headings
- Infections, Post-Infectious Disorders, Arthritis, Reactive, Guillain-Barre Syndrome, Anxiety Disorders, Depression, Bipolar Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PurWetCombination 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),
FurFatCombination 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).
PurApoCombination 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)
PurPhlCombination 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).
PurCloCombination product
(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos)
PurInfCombination product
(1) lei gong teng (Tripterygii wilfordii Radix), Huang Qin (Scutellariae Radix), Huang Lian (Coptidis Rhizoma), Huang Bai (Phellodendri Cortex), Zhi Zi (Gardeniae Fructus).
SmolivCombination 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: PurClo |
| Communication between cells | Active comparator | The communication between organs, cells, helps the damaged cells recover and reduce symptoms. Receives: Combination Product: PurInf; Combination Product: Smoliv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring symptoms
Measuring the symptoms of chest pain, cough, loss of smell, loss of taste by Visual Analog Score (VAS)
Measured: 3 months as a course
Secondary outcomes (5)
Monitoring emotion changing
measuring anxiety, depression, bipolar feeling by Visual Analog Score (VAS)
Measured: 3 months as a course.
Checking heart burn symptom
Measuring stomach reflux symptom by Visual Analog Score (VAS)
Measured: 3 months as a course.
Monitoring thyroid function
Measuring thyroid hormone3, 4 (T3,T4), thyroid-stimulating hormone (TSH) level
Measured: 3 months as a course
Monitoring liver function
Measuring alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase (ALP) recovering
Measured: 3 months as a course
Monitoring kidney function
Measuring estimated glomerular filtration rate (eGFR), creatinine (Cr.) level
Measured: 3 months as a course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Mar 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sequelae of; InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All Natural Medicine Clinic, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanzhu Hou, All Natural Medicine Clinic, LLC
- Investigators
- Wanzhu Hou, CMD, Principal investigator, All Natural Medicine Clinic, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846010
- Sponsor's protocol ID
- CHM2282395-2
- Acronym
- sequelae
- Status last verified
- May 2021
- First submitted
- 31 Mar 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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
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.
PubMed 23219392Jurewicz 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.
PubMed 30421030Wang 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.
PubMed 33177481Pollard 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.
PubMed 32991251Schvartz 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.
PubMed 33344389Smatti 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.
PubMed 31430946Ploumpidis D. Living with covid-19. Psychiatriki. 2020 Jul-Sep;31(3):197-200. doi: 10.22365/jpsych.2020.313.197. English, Greek, Modern.
PubMed 33099460Fujinami 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.
PubMed 16418524Honda 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.
PubMed 24440150
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Sequalae Caused by Post-acute Sequelae of SARS (Severe Acute Respiratory Syndrome)-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04846010
- Acronym / sponsor ID
- sequelae / CHM2282395-2
- Conditions
- Sequelae of; Infection, Post Infection Glomerulonephritis, Post-Infectious Peripheral Neuralgia, Post-Infectious Disorder (Disorder), Post-Infectious Arthritis, Post-Infectious Polyneuritis
- Keywords
- treatment of Covid-19 virus infection, COVID stress syndrome, COVID19 stress syndrome, sequelae, sequels, loss of smell, loss of taste, emotion disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- All Natural Medicine Clinic, LLCUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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。
| Arm | Type | Receives |
|---|---|---|
| antigen | Active comparator | Combination Product: PurWet, Combination Product: FurFat, Combination Product: PurApo, Combination Product: PurPhlThe 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. |
| Internal environment | Active comparator | Combination Product: PurCloThe internal environment is critical to the damaged cells recovering. Mainly it is covered by two major parts: metabolites and thrombus. |
| Communication between cells | Active comparator | Combination Product: PurInf, Combination Product: SmolivThe communication between organs, cells, helps the damaged cells recover and reduce symptoms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | antigen |
| 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 | antigen |
| 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 | antigen |
| 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). | Combination product | antigen |
| PurClo(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos) | Combination product | Internal environment |
| 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 | Communication between cells |
| 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) | Combination product | Communication between cells |
Primary outcome
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)
5 secondary outcomes
Monitoring emotion changing
Time frame: 3 months as a course.
Checking heart burn symptom
Time frame: 3 months as a course.
Monitoring thyroid function
Time frame: 3 months as a course
Monitoring liver function
Time frame: 3 months as a course
Monitoring kidney function
Time frame: 3 months as a course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- BackgroundWanzhu Hou, et al. Treating Autoimmune disease with Chinses Medicine, Elsevier, 2011
- BackgroundWannzhu Hou Cellular Structure and its Function is the key for keeling Diseases, Certification and Registration number: TXu 1-938-144 July 30, 2014
- Background: PubMed 23219392Zigmond 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.
- Background: PubMed 30421030Jurewicz 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.
- Background: PubMed 33177481Wang 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.
- Background: PubMed 32991251Pollard 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.
- Background: PubMed 33344389Schvartz 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.
- Background: PubMed 31430946Smatti 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.
- Background: PubMed 33099460Ploumpidis D. Living with covid-19. Psychiatriki. 2020 Jul-Sep;31(3):197-200. doi: 10.22365/jpsych.2020.313.197. English, Greek, Modern.
- Background: PubMed 16418524Fujinami 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.
- Background: PubMed 24440150Honda 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.
- 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 infectionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanzhu Hou, CMD principal investigator
All Natural Medicine Clinic, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PurWet, FurFat and PurApo in people with Sequelae of; Infection and Post Infection Glomerulonephritis, run by All Natural Medicine Clinic, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanzhu Hou, CMD ((301)770-4480, info@anmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring symptoms (time frame: 3 months as a course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846010, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.