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

NCT ID: NCT04380870

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2025-05-11

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.

Conditions

Coronavirus Infection

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Chinese Herbal Medicine

Chinese Herbal Medicine for suspected COVID-19 symptoms.

Chinese Herbal Medicine

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 114 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Center for Integrated Care

OTHER

Sponsor Role: lead

Responsible Party

Katherine Taromina

Instructor, Supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Taylor-Swanson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Lisa Conboy, DSc

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconness Medical Center, Harvard Medical School

Locations

Seattle Intstitute of East Asian Medicine

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa A Taylor-Swanson, PhD

Role: CONTACT

lisa.taylor-swanson@nurs.utah.edu

801-585-5486

Lisa Conboy, DSc

Role: CONTACT

lisaconboy@gmail.com

617-718-1917

Facility Contacts

Katherine Taromina, DACM

Role: primary

ktaromina@sieam.edu

206-517-4541

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Related Links

https://coronavirus.jhu.edu

Corona Resource Center

https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd

WHO Coronavirus disease (COVID-19) situation dashboard

Other Identifiers

01-04-20

Identifier Type: -

Identifier Source: org_study_id