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

September 27, 2021 updated by: Katherine Taromina, Center for Integrated Care

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • Recruiting
        • Seattle Intstitute of East Asian Medicine
        • Contact:
        • Principal Investigator:
          • Katherine Taromina, DACM
        • Sub-Investigator:
          • Lisa Taylor-Swanson, PhD
        • Sub-Investigator:
          • Lisa Conboy, ScD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 114 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported main complaint
Time Frame: 24 hours
Patient reported change
24 hours
Patient reported main complaint
Time Frame: 48 hours
Patient reported change
48 hours
Patient reported main complaint
Time Frame: 3 months
Patient reported change
3 months
Patient reported main complaint
Time Frame: 12 months
Patient reported change
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conduct qualitative analyses of data
Time Frame: 24 hours
Patient interview notes as written by clinicians.
24 hours
Conduct qualitative analyses of data
Time Frame: 48 hours
Patient interview notes as written by clinicians.
48 hours
Conduct qualitative analyses of data
Time Frame: 3 months
Patient interview notes as written by clinicians.
3 months
Conduct qualitative analyses of data
Time Frame: 12 months
Patient interview notes as written by clinicians.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Integrated Care

Collaborators

University of California, San Francisco
University of Utah

Investigators

  • Principal Investigator: Lisa Taylor-Swanson, PhD, University of Utah
  • Principal Investigator: Lisa Conboy, DSc, Beth Israel Deaconness Medical Center, Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Anticipated)

December 11, 2021

Study Completion (Anticipated)

May 11, 2025

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-04-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Confidential, de-identified,demographic and health symptoms will be collected as part of this study.

IPD Sharing Time Frame

Start with publication for a year.

IPD Sharing Access Criteria

Site Principal Investigator to review written requests from HIPPA-trained investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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