Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

Overview

An version of the standard scale for syndrome differentiation of Yin Deficiency Syndrome is not available yet for Chinese medicine. The aim of this study is to develop and validate the standard scale for syndrome differentiation of Yin Deficiency Syndrome. The study is divided into two steps. The first step is to develop the standard scale for syndrome differentiation of Yin Deficiency Syndrome through expert consultation (Delphi method). The second step is to apply the scale in the participants and find out the diagnostic cut-off value of the scale by comparing it with the gold standard.

Full Title of Study: “Establish and Validate Study of Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2022

Interventions

  • Diagnostic Test: the diagnosis for Yin Deficiency Syndrome
    • The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome

Arms, Groups and Cohorts

  • Chinese participants with Yin Deficiency Syndrome
    • The participants with Yin Deficiency syndrome were included in this study. Chinese Medicine Experts evaluated the main symptoms of Yin Deficiency syndrome, diagnosed those participants. And the participants were measured by the standard scale for syndrome differentiation of Yin Deficiency syndrome. The participants were followed up for 12 months to observe whether there were any manifestations of Yin Deficiency syndrome during the observation period.
  • Chinese participants without Yin Deficiency Syndrome
    • The participants without Yin Deficiency syndrome were included in this study. Chinese Medicine Experts evaluated the main symptoms of Yin Deficiency syndrome, diagnosed those participants. And the participants were measured by the standard scale for syndrome differentiation of Yin Deficiency syndrome. The participants were followed up for 12 months to observe whether there were any manifestations of Yin Deficiency syndrome during the observation period.

Clinical Trial Outcome Measures

Primary Measures

  • the diagnostic cut-off value of scale
    • Time Frame: 12 months
    • find out the diagnostic cut-off value of the standard scale for syndrome differentiation of Yin Deficiency Syndrome.

Secondary Measures

  • Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
    • Time Frame: 12 months
    • By comparing the consistency between the scale diagnosis and expert diagnosis, the accuracy of the scale diagnosis of Yin deficiency syndrome was judged.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject will be recruited from the current outpatients' clinic activity of the affiliated hospitals of Beijing University of Chinese Medicine and Nanjing University of Chinese Medicine. Subjects must be able to read and write in Chinese. After obtained informed consent we will ask them to participate to this study. – All the subjects need to fill in the scale of Yin Deficiency syndrome and be diagnosed by a specialist in traditional Chinese medicine (TCM) to determine whether they have Yin deficiency syndrome. The judgment of TCM experts is the gold standard. Exclusion Criteria:

  • Participates who not meet eligibility criteria

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Peking University Third Hospital
  • Collaborator
    • China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Liyuan Tao, PhD, +8610-82265571, tendytly@163.com

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