Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

• Conditions: Yin Deficiency Syndrome
• Interventions: Diagnostic Test: the diagnosis for Yin Deficiency Syndrome

• Registration Number: NCT04806490
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-21
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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.

Read More

Exclusion Criteria

• Participates who not meet eligibility criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chinese participants without Yin Deficiency Syndrome	the diagnosis for 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.
Chinese participants with Yin Deficiency Syndrome	the diagnosis for 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China