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Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19

Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04380870
Enrollment
500
Registered
2020-05-08
Start date
2020-05-11
Completion date
2025-05-11
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection

Keywords

COVID-19 symptoms, Chinese Herbal Medicine, Cough, Shortness of Breath, Fatigue, Epidemic, Infectious Disease, Dyspnea, Diarrhea, Myalgia, Nausea, Fever, Pneumonia

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTChinese 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.

Sponsors

University of Utah
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
Center for Integrated Care
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 114 Years
Healthy volunteers
No

Inclusion criteria

* Eighteen year of age. * Experienced one or more of the following symptoms in the last 28 days: cough, fever, shortness of breath, diarrhea, nausea, or abdominal pain OR am at high risk of exposure. * Have a Primary Care Provider.

Exclusion criteria

* Breastfeeding, pregnant, or expect that I might be pregnant. * Ineligible to receive a telehealth consult for any reason. * Unable to communicate in English verbally, and in writing. * Have an open legal case about my health. * Taking anticoagulants, immunosuppressants, antiseizure medications, antipsychotic medications or am in active cancer treatment * Taking medications with some risk of interaction with the herbal medicine. This will be determined at the time of the herbal consult by the clinic team. * Discretion of the practitioner or screener.

Design outcomes

Primary

MeasureTime frameDescription
Patient reported main complaint24 hoursPatient reported change

Secondary

MeasureTime frameDescription
Conduct qualitative analyses of data24 hoursPatient interview notes as written by clinicians.

Countries

United States

Contacts

Primary ContactLisa A Taylor-Swanson, PhD
lisa.taylor-swanson@nurs.utah.edu801-585-5486
Backup ContactLisa Conboy, DSc
lisaconboy@gmail.com617-718-1917

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026