Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19
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ClinicalTrials.gov Identifier: NCT04380870 |
Recruitment Status :
Recruiting
First Posted : May 8, 2020
Last Update Posted : September 28, 2021
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Condition or disease | Intervention/treatment |
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Coronavirus Infection | Dietary Supplement: Chinese Herbal Medicine |
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 |
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 |

Group/Cohort | Intervention/treatment |
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Chinese Herbal Medicine
Chinese Herbal Medicine for suspected COVID-19 symptoms.
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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 [ Time Frame: 24 hours ]Patient reported change
- Patient reported main complaint [ Time Frame: 48 hours ]Patient reported change
- Patient reported main complaint [ Time Frame: 3 months ]Patient reported change
- Patient reported main complaint [ Time Frame: 12 months ]Patient reported change
- Conduct qualitative analyses of data [ Time Frame: 24 hours ]Patient interview notes as written by clinicians.
- Conduct qualitative analyses of data [ Time Frame: 48 hours ]Patient interview notes as written by clinicians.
- Conduct qualitative analyses of data [ Time Frame: 3 months ]Patient interview notes as written by clinicians.
- Conduct qualitative analyses of data [ Time Frame: 12 months ]Patient interview notes as written by clinicians.

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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 |
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.

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
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 |
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 |
Principal Investigator: | Lisa Taylor-Swanson, PhD | University of Utah | |
Principal Investigator: | Lisa Conboy, DSc | Beth Israel Deaconness Medical Center, Harvard Medical School |
Publications:
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 symptoms Chinese Herbal Medicine Cough Shortness of Breath Fatigue Epidemic Infectious Disease |
Dyspnea Diarrhea Myalgia Nausea Fever Pneumonia |
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 |