跳至主要内容
临床试验/NCT04380870
NCT04380870招募中不适用

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

Center for Integrated Care1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Patient reported main complaint

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 114 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Patient reported main complaint

时间窗: 12 months

Patient reported change

次要结局

  • Conduct qualitative analyses of data(12 months)

研究者

发起方
Center for Integrated Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Taromina

Instructor, Supervisor

Center for Integrated Care

研究点 (1)

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