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| Name | Class |
|---|---|
| University of Utah | OTHER |
| University of California, San Francisco | OTHER |
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The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.
The purpose of this study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19 infection who participate in Chinese herbal medicine (CHM) telehealth visits and take CHM. CHM includes over 400 medicinal substances and CHM formulas are individualized at each visit according to the patient's presentation. CHM has been used to treat cough, shortness of breath, and fatigue and mechanisms of action have been investigated for SARS and H1N1 influenza prevention and treatment by anti-inflammatory effects and antiviral activity. Yet, there is a gap in our understanding of the clinical application of CHM in a community sample of individuals experiencing symptoms that may be related to COVID-19. The investigators have no pragmatic clinic data about the use of CHM for coronaviruses.
Safe and effective treatment of symptoms associated with COVID-19 is a top international priority and research is needed to better understand if CHM is a safe intervention to treat symptoms. Further, dissemination of trustworthy CHM treatment approaches for this complex and emergent condition is needed within the CHM and scientific communities.
Aim 1: Conduct quantitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.
Case series will be reported bi-weekly to CHM clinicians via the SIEAM website including exposure, comorbidities, symptom change, concurrent medications, CHM prescriptions, adverse events and usability. Data will be analyzed at the study conclusion for presentation to the scientific community.
Aim 2: Conduct qualitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.
Chart notes reflecting clinicians' clinical reasoning will be content analyzed and posted bi-weekly on the SIEAM website. This will provide timely information for the CHM clinical community from highly experienced clinicians. Data will be analyzed at the study conclusion for presentation to the scientific community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Herbal Medicine | Chinese Herbal Medicine for suspected COVID-19 symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese Herbal Medicine | Dietary Supplement | Chinese Herbal Medicine (CHM) has been used in the prevention and treatment of epidemic diseases dating back to the Han, Ming and Qing Dynasties and extending al the way through modern times. CHM formulas may contain plant elements of root, seed, back, stem or leaf in addition to minerals and other natural substances. All herbs dispensed in this trial will be from Spring Wind Herb Company. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported main complaint | Patient reported change | 24 hours |
| Patient reported main complaint | Patient reported change | 48 hours |
| Patient reported main complaint | Patient reported change | 3 months |
| Patient reported main complaint | Patient reported change | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Conduct qualitative analyses of data | Patient interview notes as written by clinicians. | 24 hours |
| Conduct qualitative analyses of data | Patient interview notes as written by clinicians. |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa A Taylor-Swanson, PhD | Contact | 801-585-5486 | lisa.taylor-swanson@nurs.utah.edu | |
| Lisa Conboy, DSc | Contact | 617-718-1917 | lisaconboy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Taylor-Swanson, PhD | University of Utah | Principal Investigator |
| Lisa Conboy, DSc | Beth Israel Deaconness Medical Center, Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Intstitute of East Asian Medicine | Recruiting | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32015507 | Background | Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3. | |
| 32215956 |
| Label | URL |
|---|---|
| Corona Resource Center | View source |
Not provided
Confidential, de-identified,demographic and health symptoms will be collected as part of this study.
Start with publication for a year.
Site Principal Investigator to review written requests from HIPPA-trained investigators.
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D003371 | Cough |
| D004417 | Dyspnea |
| D005221 | Fatigue |
| D003141 | Communicable Diseases |
| D003967 | Diarrhea |
| D063806 | Myalgia |
| D009325 | Nausea |
| D005334 | Fever |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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|
| 48 hours |
| Conduct qualitative analyses of data | Patient interview notes as written by clinicians. | 3 months |
| Conduct qualitative analyses of data | Patient interview notes as written by clinicians. | 12 months |
| Background |
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| WHO Coronavirus disease (COVID-19) situation dashboard | View source |
| D007239 |
| Infections |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D012817 | Signs and Symptoms, Digestive |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D001832 | Body Temperature Changes |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |