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
|Condition or disease||Intervention/treatment|
|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|
|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|
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.
- 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.
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, PhDfirstname.lastname@example.org|
|Contact: Lisa Conboy, DScemail@example.com|
|United States, Washington|
|Seattle Intstitute of East Asian Medicine||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Katherine Taromina, DACM 206-517-4541 firstname.lastname@example.org|
|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|