Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

Yin Deficiency Syndrome Clinical Trial

— SFYDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806490
• Other study ID #: 2018YFC1704401
• Status: Recruiting
• Start date: May 21, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Peking University Third Hospital
• Contact: Liyuan Tao, PhD
• Phone: +8610-82265571
• Email: tendytly[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Yin Deficiency
• Yin Deficiency Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences, Nanjing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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