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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380870
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : September 28, 2021
Sponsor:
Collaborators:
University of Utah
University of California, San Francisco
Information provided by (Responsible Party):
Katherine Taromina, Center for Integrated Care

Study Description
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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.

Condition or disease Intervention/treatment
Coronavirus Infection Dietary Supplement: Chinese Herbal Medicine

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : December 11, 2021
Estimated Study Completion Date : May 11, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Chinese Herbal Medicine
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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient reported main complaint [ Time Frame: 24 hours ]
    Patient reported change

  2. Patient reported main complaint [ Time Frame: 48 hours ]
    Patient reported change

  3. Patient reported main complaint [ Time Frame: 3 months ]
    Patient reported change

  4. Patient reported main complaint [ Time Frame: 12 months ]
    Patient reported change


Secondary Outcome Measures :
  1. Conduct qualitative analyses of data [ Time Frame: 24 hours ]
    Patient interview notes as written by clinicians.

  2. Conduct qualitative analyses of data [ Time Frame: 48 hours ]
    Patient interview notes as written by clinicians.

  3. Conduct qualitative analyses of data [ Time Frame: 3 months ]
    Patient interview notes as written by clinicians.

  4. Conduct qualitative analyses of data [ Time Frame: 12 months ]
    Patient interview notes as written by clinicians.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 114 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380870


Contacts
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Contact: Lisa A Taylor-Swanson, PhD 801-585-5486 lisa.taylor-swanson@nurs.utah.edu
Contact: Lisa Conboy, DSc 617-718-1917 lisaconboy@gmail.com

Locations
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United States, Washington
Seattle Intstitute of East Asian Medicine Recruiting
Seattle, Washington, United States, 98108
Contact: Katherine Taromina, DACM    206-517-4541    ktaromina@sieam.edu   
Principal Investigator: Katherine Taromina, DACM         
Sub-Investigator: Lisa Taylor-Swanson, PhD         
Sub-Investigator: Lisa Conboy, ScD         
Sponsors and Collaborators
Center for Integrated Care
University of Utah
University of California, San Francisco
Investigators
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Principal Investigator: Lisa Taylor-Swanson, PhD University of Utah
Principal Investigator: Lisa Conboy, DSc Beth Israel Deaconness Medical Center, Harvard Medical School
More Information
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Additional Information:

Publications:

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Responsible Party: Katherine Taromina, Instructor, Supervisor, Center for Integrated Care
ClinicalTrials.gov Identifier: NCT04380870    
Other Study ID Numbers: 01-04-20
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Confidential, de-identified,demographic and health symptoms will be collected as part of this study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Start with publication for a year.
Access Criteria: Site Principal Investigator to review written requests from HIPPA-trained investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Taromina, Center for Integrated Care:
COVID-19 symptoms
Chinese Herbal Medicine
Cough
Shortness of Breath
Fatigue
Epidemic
Infectious Disease
 Dyspnea
Diarrhea
Myalgia
Nausea
Fever
Pneumonia
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Communicable Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes