An observational study in Coronavirus Infection, sponsored by Center for Integrated Care. Recruiting at 1 site in United States. Open to participants aged 18 Years to 114 Years. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Center for Integrated Care · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 500 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Center for Integrated Care as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Community sample.
Exclusion Criteria:
Chinese Herbal Medicine for suspected COVID-19 symptoms.
Dietary Supplement: Chinese Herbal Medicine
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.
Patient reported main complaint
Patient reported change
Time frame: 24 hours
Patient reported main complaint
Patient reported change
Time frame: 48 hours
Patient reported main complaint
Patient reported change
Time frame: 3 months
Patient reported main complaint
Patient reported change
Time frame: 12 months
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Time frame: 24 hours
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Time frame: 48 hours
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Time frame: 3 months
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Time frame: 12 months
Plan to share: Yes — Confidential, de-identified,demographic and health symptoms will be collected as part of this study.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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