Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome (SFYDS)

Establish and Validate Study of Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Yin Deficiency Syndrome
• Intervention / Treatment: Diagnostic test: the diagnosis for Yin Deficiency Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yuan Li Tao, Ph.D; Email: tendytly@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the subjects were enrolled continuously in the TCM outpatient department. If the informed consent of the researcher is obtained, the scale measurement of the study subjects can be carried out.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: the diagnosis for Yin Deficiency Syndrome; The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome
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.	Diagnostic test: the diagnosis for Yin Deficiency Syndrome; The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: China Academy of Chinese Medical Sciences; Beijing University of Chinese Medicine; Nanjing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2019
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (ACTUAL): March 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: syndrome differentiation; standard scale; Yin Deficiency Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Yin Deficiency
• Other Study ID Numbers: 2018YFC1704401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the completion of this study and the publication of relevant research papers, all the research object data in this study will be made public to anyone, but only after de-identification.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No