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

NCT04380870 | Unknown

• 1 other identifier: 01-04-20
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Keywords

COVID-19 symptoms; Chinese Herbal Medicine; Cough; Shortness of Breath; Fatigue; Epidemic; Infectious Disease; Dyspnea; Diarrhea; Myalgia; Nausea; Fever; Pneumonia

Outcome Measures

Primary Outcomes (4)

• Patient reported main complaint

  Patient reported change

  24 hours

• Patient reported main complaint

  Patient reported change

  48 hours

• Patient reported main complaint

  Patient reported change

  3 months

• Patient reported main complaint

  Patient reported change

  12 months

Secondary Outcomes (4)

• Conduct qualitative analyses of data

  24 hours

• Conduct qualitative analyses of data

  48 hours

• Conduct qualitative analyses of data

  3 months

• Conduct qualitative analyses of data

  12 months

Study Arms (1)

Chinese Herbal Medicine

Chinese Herbal Medicine for suspected COVID-19 symptoms.

Dietary Supplement: Chinese Herbal Medicine

Interventions

Chinese Herbal Medicine 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.

Chinese Herbal Medicine

Eligibility Criteria

• Age: 18 Years - 114 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Integrated Care: lead
• University of Utah: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Seattle Intstitute of East Asian Medicine

Seattle, Washington, 98108, United States

RECRUITING

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Related Links

• Corona Resource Center
• WHO Coronavirus disease (COVID-19) situation dashboard

MeSH Terms

Conditions

Coronavirus Infections; Cough; Dyspnea; Fatigue; Communicable Diseases; Diarrhea; Myalgia; Nausea; Fever; Pneumonia

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Signs and Symptoms, Digestive; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Body Temperature Changes; Respiratory Tract Infections; Lung Diseases

Study Officials

• Lisa Taylor-Swanson, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Lisa Conboy, DSc

  Beth Israel Deaconness Medical Center, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Taylor-Swanson, PhD

CONTACT

801-585-5486; lisa.taylor-swanson@nurs.utah.edu

Lisa Conboy, DSc

CONTACT

617-718-1917; lisaconboy@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Supervisor

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: May 11, 2020
• Primary Completion: December 11, 2021
• Study Completion: May 11, 2025
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start with publication for a year.
• Access Criteria: Site Principal Investigator to review written requests from HIPPA-trained investigators.

Locations

US (1)