Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

NCT04806490 | Unknown

• 1 other identifier: 2018YFC1704401
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Yin Deficiency Syndrome

Keywords

standard scale; syndrome differentiation; Yin Deficiency Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

  12 months

Study Arms (2)

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

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

Interventions

the diagnosis for Yin Deficiency Syndrome DIAGNOSTIC_TEST

The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome

Chinese participants with Yin Deficiency Syndrome; Chinese participants without Yin Deficiency Syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participates who not meet eligibility criteria

Sponsors & Collaborators

• Peking University Third Hospital: lead
• China Academy of Chinese Medical Sciences: collaborator
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• Beijing University of Chinese Medicine: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Central Study Contacts

Liyuan Tao, PhD

CONTACT

+8610-82265571; tendytly@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: May 21, 2019
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)