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

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380870
• Other study ID #: 01-04-20
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: May 11, 2025

Study information

• Verified date: September 2021
• Source: Center for Integrated Care
• Contact: Lisa A Taylor-Swanson, PhD
• Phone: 801-585-5486
• Email: lisa.taylor-swanson[@]nurs.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 11, 2025
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 114 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Intstitute of East Asian Medicine	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Center for Integrated Care	University of California, San Francisco, University of Utah

Country where clinical trial is conducted

United States, 

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported main complaint	Patient reported change	24 hours
Primary	Patient reported main complaint	Patient reported change	48 hours
Primary	Patient reported main complaint	Patient reported change	3 months
Primary	Patient reported main complaint	Patient reported change	12 months
Secondary	Conduct qualitative analyses of data	Patient interview notes as written by clinicians.	24 hours
Secondary	Conduct qualitative analyses of data	Patient interview notes as written by clinicians.	48 hours
Secondary	Conduct qualitative analyses of data	Patient interview notes as written by clinicians.	3 months
Secondary	Conduct qualitative analyses of data	Patient interview notes as written by clinicians.	12 months

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